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.

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...

Analysis of ascending and transverse aortic arch repair in octogenarians.

BACKGROUND: Increasing numbers of older patients are requiring complex thoracic aortic surgery. This retrospective study analyzed early and late outcomes after ascending and transverse arch surgery using hypothermic circulatory arrest (HCA). METHODS: Between January 1991 and December 2006, 779 patients requiring HCA were treated. Outcomes are reported by age group: group 1, 80 years or more (37, 4.8%); and group 2, less than 80 years (742, 95.2%). Univariate and multivariate analyses were used to identify risk factors for morbidity and mortality. RESULTS: Early mortality and stroke did not differ between groups. Thirty-day mortality was13.5% (5 of 37) in group 1 and 10% (78 of 742) in group 2 (p = 0.57). Stroke occurred in 8% (3 of 37) of group 1 patients and 2.7% (20 of 742) of group 2 patients (p = 0.09). Predictors of stroke were prior stroke (p = 0.003) and pump time (p = 0.02). Predictors of early mortality were low glomerular filtration rate (p = 0.0001), long cardiopulmonary bypass time (p = 0.0001), and emergent repair (p = 0.0009). Retrograde cerebral perfusion was protective against stroke (p = 0.0001) and reduced early mortality (p = 0.02). Age was not a predictor of stroke (p = 0.12) or early mortality (p = 0.39). Survival in group 1 compared with the age-matched US population at 1 year was 56% versus 86% (p = 0.02); at 2 years, 48% versus 76% (p = 0.03); at 5 years, 36% versus 48% (not significant); and at 10 years, 20% versus 20%. CONCLUSIONS: Ascending and aortic arch surgery in octogenarians involving profound HCA resulted in reasonable morbidity and short- and long-term mortality rates. The use of profound HCA for aortic surgery remains warranted in octogenarians.

Management of a large bronchopleural fistula using a tracheobronchial stent.

Bronchopleural fistula, one of the most serious complications following pneumonectomy, has a complicated treatment protocol and carries a high mortality rate. We present a case report of a 75-year-old female with squamous cell carcinoma of the lower lobe with positive peribronchial hilar nodes who underwent a right pneumonectomy. She represented with a large bronchopleural fistula one month postoperatively, eventually treated by a novel tracheobronchial stenting procedure.

Intimo-intimal intussusception of the aorta.

A 50-year-old man presented with acute onset of chest pain. Subsequent transesophageal echocardiography and computed tomography scan showed absence of a flap in the ascending aorta and a clear dissection flap involving the arch and descending aorta. Magnetic resonance imaging showed a tear and a small flap in the right coronary sinus. During surgery, we found a total circumferential intimal tear at the sinotubular junction with intimo-intimal intussusception of the internal channel into the arch. Dissection without intimal flap and aortic intussusception is a rare form of type A dissection, which is difficult to diagnose on routine investigations and can delay treatment.

Large retrosternal goitre: a diagnostic and management dilemma.

A substernal goitre is of clinical significance because its growth between the sternum anteriorly and vertebral bodies posteriorly leads to impingement on the surrounding structures and compressive symptoms. The incidence of substernal goitre is documented to vary between .02 and .5%. It accounts for 3-12% of mediastinal masses and is the most common superior mediastinal mass. This condition is important because it presents a diagnostic dilemma as its size and compressive symptoms mimic malignant disease, and an operative dilemma for the approach to its management. We present one of the largest reported retrosternal goitre cases in the literature.

Factors influencing the mean postoperative gradients across stentless porcine valves.

BACKGROUND: To study the preoperative and intraoperative variables influencing the mean post-operative transvalvular gradient across stentless porcine valves. METHODS: From 1995 to 2002, 84 patients underwent stentless valve insertion. The mean age was 73 years, and 63% were male. The valve pathology was aortic stenosis (AS) in 79%, aortic regurgitation (AR) in 12%, and mixed in 9%. Valve sizes ranged from 21 to 29 with size 27 being most frequent. 54% of patients had concomitant procedures. Patients had at least yearly clinical and echocardiographic follow-up. RESULTS: There was no operative mortality. 9.5% of the patients had significant postoperative complications. The average echo interval was 18.6 months (range 1-88). The overall mean transvalvular gradient was 9.88+/-5.67 (SD) mmHg. Variables associated with significantly reduced gradients were: larger valve sizes (p=0.002), younger age (p=0.05), pre-op AR (p=0.008), and increasing post-operative interval (p=0.05). The mean gradients decreased by 0.28 mmHg for each post-operative year. The method of implantation did not significantly affect gradients (p=0.26). CONCLUSIONS: Excellent mean transvalvular gradients were achieved with stentless valves studied, with a low operative risk. The gradients did not appear to be related to intra-operative factors, suggesting that insertion techniques can be tailored to suit patient conditions and surgeon preferences.

Coronary artery bypass surgery in undiagnosed traumatic pericardial rupture--25 years later.

A 55-year-old man was electively admitted for coronary artery bypass surgery. His admission chest X-ray showed an abnormal cardiac silhouette with complete leftward displacement. He had a past history of blunt thoracic trauma due to a motor vehicle accident treated conservatively. We present our findings and surgical difficulty during an operation on a patient with a previously undiagnosed pericardial rupture. This is the first reported case of its kind in the cardiac surgical literature.

Clopidogrel and bleeding after coronary artery bypass graft surgery.

BACKGROUND: There is evidence that clopidogrel (with or without aspirin) confers superior outcomes in patients with coronary artery disease. The purpose of this study is to review the effect of preoperative clopidogrel administration on clinical outcome, bleeding complications and resource utilization after coronary artery bypass graft surgery. METHODS: Patient data were prospectively collected from 919 patients who had isolated coronary surgery during the period 2000 to 2003. Outcome comparisons were studied, firstly between patients who received preoperative clopidogrel with those who did not, and secondly between patients on clopidogrel only, aspirin only, both or neither medications. RESULTS: Twenty-four patients (2.6%) were on clopidogrel only, 598 (65.1%) were on aspirin only, 61 (6.6%) were on both, and 236 (25.7%) were on neither. Clopidogrel (n = 85) versus no clopidogrel (n = 834): there were no significant differences in the off-pump patients. In the on-pump patients, the clopidogrel group had significantly increased bleeding (p = 0.02), blood transfused (p = 0.01), intensive care (p = 0.03), and hospital stays (p = 0.03). There were no significant differences in surgical reexploration, perioperative myocardial infarction, intraoperative balloon pump use, inotropic support or 30-day mortality. Clopidogrel versus aspirin versus both versus neither: patients on both clopidogrel and aspirin had significantly more postoperative bleeding than patients on aspirin alone or on neither medication. CONCLUSIONS: The preoperative use of clopidogrel in patients undergoing coronary artery bypass graft surgery showed limited clinical benefits; however, its use significantly increased the risk of bleeding, blood transfusion, and resource utilization.

Has the in situ right internal thoracic artery been overlooked? An angiographic study of the radial artery, internal thoracic arteries and saphenous vein graft patencies in symptomatic patients.

OBJECTIVE: The right internal thoracic artery is being used infrequently despite favorable observational angiographic data. Conversely, the radial artery utilization has increased with only limited data available. The purpose of this paper is to re-evaluate the roles of the right internal thoracic artery and the radial artery grafts. METHODS: We reviewed all ischemia-directed coronary angiographic procedures from January 1996 to December 2003. A total of 219 patients had primary coronary artery bypass grafting with an internal thoracic artery and a radial artery as two of the bypass grafts. Six hundred and seventy-nine (679) graft angiograms (45 saphenous vein, 363 radial artery, 54 right internal thoracic artery and 217 left internal thoracic artery) were studied. The mean period from operation to re-angiogram was 1104+/-761 days. Angiographic outcomes were divided into groups as: (1) patent (<50% stenosis) or (2) failed (>or=50% stenosis, string sign or occluded). A generalized linear mixed model was used to analyze predictors of graft patency. Turnbull's estimates of cumulative patency were used to compare graft failure rates over time. RESULTS: A total of 632/679 (93%) grafts were patent and 47/679 (7%) grafts had failed. Empirical saphenous vein graft patency was 40/45 (89%), radial artery patency 329/363 (91%), right internal thoracic artery patency 51/54 (94%) and left internal thoracic artery patency 212/217 (98%). Pairwise comparisons of patency from the generalized linear mixed model were: LITA>RITA, OR=1.5 (P=0.5); LITA>RA, OR=5.7 (P<0.001); LITA>SV, OR=6.5 (P<0.001); RITA>RA, OR=3.9 (P=0.01); RITA>SV, OR=4.4 (P=0.01); RA>SV, OR=1.1 (P=0.7). Five-year patency estimates from the Turnbull's model were the left internal thoracic artery (95.9%), right internal thoracic artery (91.2%), the radial artery (90.6%) and the saphenous vein (81.8%). CONCLUSIONS: Consideration should be given to the routine use of both internal thoracic arteries for coronary artery bypass grafting. When additional grafts are required, there is no evidence to suggest that either the radial artery or saphenous vein is superior.

Factors affecting patency of internal thoracic artery graft: clinical and angiographic study in 1434 symptomatic patients operated between 1982 and 2002.

OBJECTIVE: The purpose is to define factors influencing long-term patency of the internal thoracic artery (ITA) to optimize the operative strategy. METHODS: 1482 left internal thoracic artery (LITA) and 636 right internal thoracic artery (RITA) symptom-directed angiograms were studied in 1434 patients. Data were prospectively collected from patients who had primary coronary artery bypass surgery during the period 1982-2002. The mean age of patients was 59 years; 85% were male. The mean period from operation to re-angiogram was 80 months. LITA was grafted to left anterior descending coronary artery (LAD) in 82% of cases, RITA to right coronary artery (RCA) in 40% and circumflex artery in 35% of cases. Graft failure was defined as > or =80% stenosis. RESULTS: 96.3% of LITA and 88.1% of RITA grafts were patent. No patient variables were significantly associated with graft patency (age, gender, diabetes, hypertension, LVEF, NYHA, AMI). Target coronary artery was associated with patency of both LITA and RITA grafts with maximum patency when grafted to LAD (P = 0.02) RITA had the worst patency to RCA, patency for the left system was identical to LITA. Proximal anastomosis to aorta (free RITA) had significantly better patency when compared with in situ RITA to RCA system (P = 0.005) while similar patency when grafted to left system. ITA diameter and target artery diameter were not associated with graft patency. Recent operations had better RITA patency (P = 0.03). The interval from operation to angiogram was not associated with ITA patency (96% patency for LITA and 88% patency for RITA, remained stable when studied at <1, 1-4, 5-9, 10-14 and >15 years). CONCLUSIONS: Even in a patient cohort that had adverse symptoms, excellent LITA and RITA patency was achieved which almost remained constant through all time intervals studied.

Patency of the radial artery graft: angiographic study in 209 symptomatic patients operated between 1995 and 2002 and review of the current literature.

OBJECTIVES: The purpose of this study is to define the long-term patency of the radial artery (RA) graft and review the current literature. METHODS: Two hundred and eighty-six RA symptom-directed graft angiograms were studied in 209 patients. The preoperative patient characteristics and intraoperative variables were collected prospectively from patients who had primary coronary artery bypass grafting between 1995 and 2002. A total of 166 (79%) patients were male with a mean age of 65 years. The mean period from operation to re-angiogram was 35 months. Actuarial techniques are not valid in graft patency studies as the time when the graft occluded is not known. Therefore, RA patency was analyzed at four categorical time intervals. The RA was grafted to the left anterior descending artery (LAD) in six patients (2%), diagonal (DIAG) in 29 (10%), obtuse marginal (OM) in 166 (58%), right coronary artery (RCA) in 9 (3%) and posterior descending artery (PDA) in 76 (27%) cases. The graft failure was defined as >or=80% stenosis. RESULTS: A total of 259 (91%) grafts were patent and 26 (9%) had failed. Most grafts were widely patent or occluded. The LAD/DIAG patency was 30/35 (86%), OM patency 154/166 (93%) and RCA/PDA patency 79/84 (94%). The interval from surgery to angiogram did not affect the RA graft patency (86% at <1 year, 95% at 1-3 years, 89% at 4-5 years, 96% at >5 years). CONCLUSIONS: Even in a patient cohort with adverse symptoms, excellent RA patency was achieved that remained almost constant through all time intervals studied. Better selection, harvesting and preservation may further improve early patency.

Survival after myocardial revascularization for ischemic cardiomyopathy: a prospective ten-year follow-up study.

OBJECTIVE: The aim was to prospectively analyze all-cause mortality, predictors of survival, and late functional results after myocardial revascularization for ischemic cardiomyopathy over a 10-year follow-up. METHODS: We prospectively studied 57 patients with stable coronary artery disease and poor left ventricular ejection function (<35%), enrolled between 1989 and 1994. Stress thallium was analyzed in 37 patients to identify reversible ischemia. To avoid patients with a stunned myocardium, we excluded those with unstable angina or myocardial infarction within the previous 4 weeks. Mean age of the patients was 67 +/- 8 years, and 93% of patients were men. Mean left ventricular ejection fraction was 0.28 +/- 0.04, 50% were in Canadian Cardiovascular Society angina class III-IV, and 65% were in New York Heart Association functional class III-IV. RESULTS: Operative mortality was 1.7% (1/57). The mean left ventricular ejection fraction (0.30) at 15 months postoperatively did not change from before operation (0.28, P =.09). There were 8 deaths at 1 year and 42 deaths over the course of the study, producing a survival of 82.5% at 1 year, 55.7% at 5 years, and 23.9% at 10 years (95% confidence interval: 14.6%-39.1%). Symptom-free survival was 77.2% at 1 year and 20.3% at 10 years. The leading cause of death was heart failure in 29% (12/42). Multivariate analysis showed that large reversible defects on stress thallium were associated with improved left ventricular ejection fraction at 1 year (P =.01) but only male sex was associated with improved long-term survival (P =.036). CONCLUSIONS: Myocardial revascularization for ischemic cardiomyopathy is associated with good functional relief from the symptoms of angina initially and, to a lesser extent, heart failure. Revascularization may have the advantage of preserving the remaining left ventricular function. However, the long-term mortality remains high.

Factors affecting saphenous vein graft patency: clinical and angiographic study in 1402 symptomatic patients operated on between 1977 and 1999.

BACKGROUND: The purpose of this study was to find the preoperative and intraoperative factors that affect vein graft patency. METHODS: A total of 3715 graft angiograms in 1607 patients were studied for recurrence of angina. The preoperative patient characteristics and intraoperative variables were prospectively collected from patients who had primary coronary artery bypass grafting during the period from 1977 to 1999. A total of 1339 (83%) patients were male, with a mean age of 59 years. The mean period from operation to reangiogram was 99 months. The saphenous vein was grafted to the left anterior descending artery in 557 (15%), to the diagonal artery in 669 (18%), to the obtuse marginal artery in 1300 (35%), to the right coronary artery in 409 (11%), and to the posterior descending artery in 780 (21%) cases. Graft failure was defined as >or=80% stenosis. RESULTS: During the course of the study, 2266 (61%) grafts were patent, and 1449 (39%) had failed. The patient variables that significantly reduced graft patency were a younger age (P <.001) and an ejection fraction <30% (P =.047). Operative variables associated with reduced graft patency were small coronary artery diameter (P <.001), large conduit diameter (P =.001), and the coronary artery grafted (lowest patency in the right coronary artery and maximum patency in the left anterior descending artery territory; P =.002). The interval from operation to repeat angiogram (P <.001, with 78% patent at 1 year, 78% at 5 years, 60% at 10 years, and 50% at 15 years) and the year in which the operation was performed (more recent operations had better patency; P <.001) significantly affected graft patency. CONCLUSIONS: Saphenous vein graft patency improved over the course of the study. The best results were obtained in older patients with good left ventricular function. Large-caliber arteries on the left system, when grafted with a small-diameter vein, were associated with the best outcome.