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Blood transfusion is associated with prolonged duration of mechanical ventilation in infants undergoing reparative cardiac surgery
Kipps AK, Wypij D, Thiagarajan RR, Bacha EA, Newburger JW
Pediatric Critical Care Medicine. 2011;12((1):):52-6.
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Abstract
OBJECTIVE Perioperative transfusion has adverse effects in adults undergoing cardiac surgery. We sought to investigate whether greater use of blood and blood products might be an independent predictor of prolonged postoperative recovery, indicated by duration of mechanical ventilation (DMV), after reparative infant heart surgery. DESIGN Secondary analysis of prospectively collected data from two randomized trials of hematocrit strategy during cardiopulmonary bypass in infant heart surgery to explore the association of DMV with perioperative transfusion and other variables. SETTING Tertiary pediatric hospital. PATIENTS Two hundred seventy infants undergoing two ventricle corrective cardiac surgery without aortic arch reconstruction. MEASUREMENTS AND MAIN RESULTS In univariable analyses, longer DMV was associated with younger age and lower weight at surgery, diagnostic group, and higher intraoperative and postoperative blood product transfusion (each p < .001). In multivariable proportional hazard regression, longer total support time and greater intraoperative and early postoperative blood products per kg were the strongest predictors of longer DMV. Patients in the highest tertile of intraoperative blood products per kg had an instantaneous risk of being extubated approximately half that of patients in the lowest tertile (hazard ratio, 0.51; 95% confidence interval, 0.35, 0.73). Patients who received any blood products on postoperative day 1, compared with those who did not, had a hazard ratio for extubation of 0.65 (95% confidence interval, 0.50, 0.85). CONCLUSIONS In this exploratory secondary analysis of infants undergoing two ventricular repair of congenital heart disease without aortic arch obstruction, greater intraoperative and early postoperative blood transfusion emerged as potential important risk factors for longer DMV. Future prospective clinical trials are needed to determine whether reduction in blood product administration hastens postoperative recovery after infant heart surgery.
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The influence of hemodilution on outcome after hypothermic cardiopulmonary bypass: results of a randomized trial in infants
Jonas RA, Wypij D, Roth SJ, Bellinger DC, Visconti KJ, du Plessis AJ, Goodkin H, Laussen PC, Farrell DM, Bartlett J, et al
The Journal of Thoracic and Cardiovascular Surgery. 2003;126((6):):1765-74.
Abstract
BACKGROUND We hypothesized that cognitive impairment and hemodynamic instability after infant cardiac surgery with cardiopulmonary bypass might be exacerbated by hemodilution. METHODS In a single-center randomized trial with blinded assessment of outcomes, we compared use of 2 hemodilution protocols during hypothermic cardiopulmonary bypass with infant cardiac surgery. The primary perioperative end point was lowest cardiac index in the first 24 hours postoperatively, and primary end points at age 1 year were scores on the Psychomotor Development Index and Mental Developmental Index of the Bayley Scales. RESULTS Among 147 subjects, 74 were assigned to the lower-hematocrit strategy (21. 5% +/- 2. 9%, mean +/- SD at onset of low-flow bypass) and 73 to the higher-hematocrit strategy (27. 8% +/- 3. 2%). In intent-to-treat analyses the lower-hematocrit group had lower nadirs of cardiac index (P =. 02), higher serum lactate levels 60 minutes after cardiopulmonary bypass (P =. 03), and a greater percentage increase in total body water on the first postoperative day (P =. 006). Blood product use and adverse events were similar in the 2 groups. At age 1 year (113 children), the lower-hematocrit group had worse scores on the Psychomotor Development Index (81. 9 +/- 15. 7 vs 89. 7 +/- 14. 7, P =. 008), as well as more Psychomotor Development Index scores at least 2 SDs below the population mean (16/56 [29%] vs 5/53 [9%], P =. 01). The groups had similar Mental Developmental Index scores and findings on neurologic examination. Inferences using hematocrit as a continuous variable were similar to those based on intent-to-treat analyses. CONCLUSIONS Hemodilution to a hematocrit level in wide use for cardiopulmonary bypass and thought to be safe is associated with adverse perioperative and developmental outcomes in infants.
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A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome
Newburger JW, Takahashi M, Beiser AS, Burns JC, Bastian J, Chung KJ, Colan SD, Duffy CE, Fulton DR, Glode MP,, et al
New England Journal of Medicine. 1991;324((23):):1633-9.
Abstract
BACKGROUND Treatment of acute Kawasaki syndrome with a four-day course of intravenous gamma globulin, together with aspirin, has been demonstrated to be safe and effective in preventing coronary-artery lesions and reducing systemic inflammation. We hypothesized that therapy with a single, very high dose of gamma globulin would be at least as effective as the standard regimen. METHODS We conducted a multicenter, randomized, controlled trial involving 549 children with acute Kawasaki syndrome. The children were assigned to receive gamma globulin either as a single infusion of 2 g per kilogram of body weight over 10 hours or as daily infusions of 400 mg per kilogram for four consecutive days. Both treatment groups received aspirin (100 mg per kilogram per day through the 14th day of illness, then 3 to 5 mg per kilogram per day). RESULTS The relative prevalence of coronary abnormalities, adjusted for age and sex, among patients treated with the four-day regimen, as compared with those treated with the single-infusion regimen, was 1.94 (95 percent confidence limits, 1.01 and 3.71) two weeks after enrollment and 1.84 (95 percent confidence limits, 0.89 and 3.82) seven weeks after enrollment. Children treated with the single-infusion regimen had lower mean temperatures while hospitalized (day 2, P less than 0.001; day 3, P = 0.004), as well as a shorter mean duration of fever (P = 0.028). Furthermore, in the single-infusion group the laboratory indexes of acute inflammation moved more rapidly toward normal, including the adjusted serum albumin level (P = 0.004), alpha 1-antitrypsin level (P = 0.007), and C-reactive protein level (P = 0.017). Lower IgG levels on day 4 were associated with a higher prevalence of coronary lesions (P = 0.005) and with a greater degree of systemic inflammation. The two groups had a similar incidence of adverse effects (including new or worsening congestive heart failure in nine children), which occurred in 2.7 percent of the children overall. All the adverse effects were transient. CONCLUSIONS In children with acute Kawasaki disease, a single large dose of intravenous gamma globulin is more effective than the conventional regimen of four smaller daily doses and is equally safe.
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Left ventricular contractility and function in Kawasaki syndrome. Effect of intravenous gamma-globulin
Newburger JW, Sanders SP, Burns JC, Parness IA, Beiser AS, Colan SD
Circulation. 1989;79((6):):1237-46.
Abstract
To investigate the effect of Kawasaki syndrome on myocardial function, as well as the influence of high-dose intravenous gamma-globulin therapy on resolution of functional abnormalities, we studied 98 patients with Kawasaki syndrome during five time intervals from onset of illness: 1) 10 days or less, 2) 11-31 days, 3) 1-3 months, 4) 3-12 months, and 5) 1-3 years. Normal controls included 48 children under age 8 years, without known cardiovascular disease. Using two-dimensional directed M-mode echocardiograms, we obtained chamber dimensions, fractional shortening, rate-corrected velocity of shortening (Vcfc) adjusted for end-systolic wall stress, and early diastolic function parameters that included adjusted peak rates of left ventricular dimension change, wall thinning, and their respective timing. Left ventricular systolic and diastolic dimensions were larger (both p less than 0.01) in patients than in normal subjects in period 1. Stress-adjusted Vcfc was much lower in patients in the 3 months after disease onset; by period 5, contractility was comparable in patients and normal subjects. Adjusted indexes of early diastolic function did not differ significantly between patients and normal subjects. To investigate the effect of gamma-globulin, we analyzed data on 47 patients prospectively randomized to therapy with aspirin alone (n = 19, 40%) or to aspirin plus gamma-globulin, 400 mg/kg/day for 4 consecutive days (n = 28, 60%). In period 1, before treatment, the two groups had mean fractional shortening and stress-adjusted Vcfc comparable to each other but much lower than those of normal subjects (p less than or equal to 0.001). Patients treated with aspirin alone continued to have diminished fractional shortening and Vcfc compared with normal subjects in periods 2, 3, and 4 (all p less than or equal to 0.05). In contrast, fractional shortening and Vcfc in gamma-globulin-treated patients in these periods were comparable to those of normal subjects. By period 5, no difference was detected in systolic function or contractility between either treatment group and normal subjects. We conclude that early abnormalities of left ventricular contractility and myocardial function, as assessed by echocardiography, generally resolve by 1-3 years after disease onset and that recovery is accelerated by administration of IVGG in the acute phase.
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Reversal of lymphocyte activation in vivo in the Kawasaki syndrome by intravenous gammaglobulin
Leung DY, Burns JC, Newburger JW, Geha RS
Journal of Clinical Investigation. 1987;79((2):):468-72.
Abstract
The effect of intravenous gammaglobulin (IVGG) on the immunoregulatory abnormalities found during acute Kawasaki syndrome (KS) was studied in a randomized trial of IVGG plus aspirin (ASA) versus ASA alone. Before therapy, patients in each treatment group had increased numbers of circulating HLA-DR-bearing Leu 3+ helper T cells, a deficiency of Leu 2+ suppressor/cytotoxic T cells, and increased levels of spontaneous IgG and IgM synthesis by peripheral blood mononuclear cells. There were no significant differences (P greater than 0.1) between immunologic parameters measured on day 1 and day 4 in the ASA-treated group. In contrast, patients treated with ASA plus IVGG had by day 4 a highly significant decrease in HLA-Dr+ Leu 3+ helper T cells (P less than 0.001), an increase in Leu 2+ suppressor/cytotoxic T cells (P less than 0.01), and a decrease in spontaneous IgG (P less than 0.01) and IgM synthesis (P less than 0.001). These changes were associated with a reduction in the secretion of T cell-derived B cell helper factors (P less than 0.001). These findings indicate that treatment with IVGG suppresses the marked T and B cell activation found in patients with acute KS.
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U.S. gamma globulin trial
Newburger JW
Progress in Clinical & Biological Research. 1987;250:441-3.
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The treatment of Kawasaki syndrome with intravenous gamma globulin
Newburger JW, Takahashi M, Burns JC, Beiser AS, Chung KJ, Duffy CE, Glode MP, Mason WH, Reddy V, Sanders SP,, et al
New England Journal of Medicine. 1986;315((6):):341-7.
Abstract
We compared the efficacy of intravenous gamma globulin plus aspirin with that of aspirin alone in reducing the frequency of coronary-artery abnormalities in children with acute Kawasaki syndrome in a multicenter, randomized trial. Children randomly assigned to the gamma globulin group received intravenous gamma globulin, 400 mg per kilogram of body weight per day, for four consecutive days; both treatment groups received aspirin, 100 mg per kilogram per day, through the 14th day of illness, then 3 to 5 mg per kilogram per day. Two-dimensional echocardiograms were interpreted blindly and independently by two or more readers. Two weeks after enrollment, coronary-artery abnormalities were present in 18 of 78 children (23 percent) in the aspirin group, as compared with 6 of 75 (8 percent) in the gamma globulin group (P = 0.01). Seven weeks after enrollment, abnormalities were present in 14 of 79 children (18 percent) in the aspirin group and in 3 of 79 (4 percent) in the gamma globulin group (P = 0.005). No child had serious adverse effects from receiving gamma globulin. We conclude that high-dose intravenous gamma globulin is safe and effective in reducing the prevalence of coronary-artery abnormalities when administered early in the course of Kawasaki syndrome.