scholarly journals Diagnostic and therapeutic medical devices for safer blood management in cardiac surgery: systematic reviews, observational studies and randomised controlled trials

2017 ◽  
Vol 5 (17) ◽  
pp. 1-406 ◽  
Author(s):  
Gavin J Murphy ◽  
Andrew D Mumford ◽  
Chris A Rogers ◽  
Sarah Wordsworth ◽  
Elizabeth A Stokes ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Applied Research ◽  
Near Infrared ◽  
Predictive Accuracy ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Controlled Trials ◽  
Red Cell ◽  
Red Cell Transfusion

BackgroundAnaemia, coagulopathic bleeding and transfusion are strongly associated with organ failure, sepsis and death following cardiac surgery.ObjectiveTo evaluate the clinical effectiveness and cost-effectiveness of medical devices used as diagnostic and therapeutic tools for the management of anaemia and bleeding in cardiac surgery.Methods and resultsWorkstream 1 – in the COagulation and Platelet laboratory Testing in Cardiac surgery (COPTIC) study we demonstrated that risk assessment using baseline clinical factors predicted bleeding with a high degree of accuracy. The results from point-of-care (POC) platelet aggregometry or viscoelastometry tests or an expanded range of laboratory reference tests for coagulopathy did not improve predictive accuracy beyond that achieved with the clinical risk score alone. The routine use of POC tests was not cost-effective. A systematic review concluded that POC-based algorithms are not clinically effective. We developed two new clinical risk prediction scores for transfusion and bleeding that are available as e-calculators. Workstream 2 – in the PAtient-SPecific Oxygen monitoring to Reduce blood Transfusion during heart surgery (PASPORT) trial and a systematic review we demonstrated that personalised near-infrared spectroscopy-based algorithms for the optimisation of tissue oxygenation, or as indicators for red cell transfusion, were neither clinically effective nor cost-effective. Workstream 3 – in the REDWASH trial we failed to demonstrate a reduction in inflammation or organ injury in recipients of mechanically washed red cells compared with standard (unwashed) red cells.LimitationsExisting studies evaluating the predictive accuracy or effectiveness of POC tests of coagulopathy or near-infrared spectroscopy were at high risk of bias. Interventions that alter red cell transfusion exposure, a common surrogate outcome in most trials, were not found to be clinically effective.ConclusionsA systematic assessment of devices in clinical use as blood management adjuncts in cardiac surgery did not demonstrate clinical effectiveness or cost-effectiveness. The contribution of anaemia and coagulopathy to adverse clinical outcomes following cardiac surgery remains poorly understood. Further research to define the pathogenesis of these conditions may lead to more accurate diagnoses, more effective treatments and potentially improved clinical outcomes.Study registrationCurrent Controlled Trials ISRCTN20778544 (COPTIC study) and PROSPERO CRD42016033831 (systematic review) (workstream 1); Current Controlled Trials ISRCTN23557269 (PASPORT trial) and PROSPERO CRD4201502769 (systematic review) (workstream 2); and Current Controlled Trials ISRCTN27076315 (REDWASH trial) (workstream 3).FundingThis project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full inProgramme Grants for Applied Research; Vol. 5, No. 17. See the NIHR Journals Library website for further project information.

scholarly journals Effects of cerebral near-infrared spectroscopy on the outcome of patients undergoing cardiac surgery: a systematic review of randomised trials

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016613 ◽  
Author(s):  
Giuseppe Filiberto Serraino ◽  
Gavin J Murphy
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Infrared Spectroscopy ◽  
Resource Use ◽  
Near Infrared ◽  
Cerebral Oxygenation ◽  
Meta Analysis ◽  
Red Cell ◽  
Randomised Trials ◽  
Red Cell Transfusion

ObjectivesGoal-directed optimisation of cerebral oxygenation using near-infrared spectroscopy (NIRS) during cardiopulmonary bypass is widely used. We tested the hypotheses that the use of NIRS cerebral oximetry results in reductions in cerebral injury (neurocognitive function, serum biomarkers), injury to other organs including the heart and brain, transfusion rates, mortality and resource use.DesignSystematic review and meta-analysis.SettingTertiary cardiac surgery centres in North America, Europe and Asia.ParticipantsA search of Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Medline, Embase, and the Cumulative Index to Nursing and Allied Health Literature Plus from inception to November 2016 identified 10 randomised trials, enrolling a total of 1466 patients, all in adult cardiac surgery.InterventionsNIRS-based algorithms designed to optimise cerebral oxygenation versus standard care (non-NIRS-based) protocols in cardiac surgery patients during cardiopulmonary bypass.Outcome measuresMortality, organ injury affecting the brain, heart and kidneys, red cell transfusion and resource use.ResultsTwo of the 10 trials identified in the literature search were considered at low risk of bias. Random-effects meta-analysis demonstrated similar mortality (risk ratio (RR) 0.76, 95% CI 0.30 to 1.96), major morbidity including stroke (RR 1. 08, 95% CI 0.40 to 2.91), red cell transfusion and resource use in NIRS-treated patients and controls, with little or no heterogeneity. Grades of Recommendation, Assessment, Development and Evaluation of the quality of the evidence was low or very low for all of the outcomes assessed.ConclusionsThe results of this systematic review did not support the hypotheses that cerebral NIRS-based algorithms have clinical benefits in cardiac surgery.Trial registration numberPROSPERO CRD42015027696.

Clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators for arrhythmias: A systematic review and economic evaluation

2007 ◽  
Vol 23 (1) ◽  
pp. 63-70 ◽  
Author(s):  
Jackie Bryant ◽  
Hakan Brodin ◽  
Emma Loveman ◽  
Andrew Clegg
Keyword(s):  
Systematic Review ◽  
Cost Effectiveness ◽  
Cardiac Death ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Controlled Trials ◽  
Implantable Cardioverter Defibrillators ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Cardioverter Defibrillators

Objectives:The clinical effectiveness and cost-effectiveness of implantable cardioverter defibrillators (ICD) for arrhythmias was assessed.Methods:A systematic review of the literature of systematic reviews and randomized controlled trials that reported mortality outcomes associated with implantable cardioverter defibrillators compared with antiarrhythmic drug therapy in people at risk of sudden cardiac death due to arrhythmias was undertaken. Economic evaluations were also sought. Inclusion criteria, data extraction, and quality assessment were undertaken by standard methodology. A decision analytic model was constructed using best available evidence to determine cost-effectiveness in a UK setting.Results:Eight randomized controlled trials, two systematic reviews, and a meta-analysis met the inclusion criteria and were of variable quality. Evidence suggests that ICDs reduce mortality in both secondary and primary prevention, although the magnitude of benefit depends on baseline risk for sudden cardiac death. Incremental cost per quality-adjusted life year ranged from £52,000 ($98,000) to over £200,000 ($379,000), depending on mortality risk and assumptions made.Conclusions:Evidence suggests that ICDs reduce total mortality but may be cost-effective only in some subgroups of patients at high risk of ventricular arrhythmias. Further research is needed on risk stratification of patients in whom ICDs are most likely to be clinically and cost-effective.

scholarly journals The clinical effectiveness of transurethral incision of the prostate: a systematic review of randomised controlled trials

2009 ◽  
Vol 28 (1) ◽  
pp. 23-32 ◽  
Author(s):  
Tania Lourenco ◽  
Matthew Shaw ◽  
Cynthia Fraser ◽  
Graeme MacLennan ◽  
James N’Dow ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Clinical Effectiveness ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Transurethral Incision

scholarly journals Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery

2017 ◽  
Vol 377 (22) ◽  
pp. 2133-2144 ◽  
Author(s):  
C. David Mazer ◽  
Richard P. Whitlock ◽  
Dean A. Fergusson ◽  
Judith Hall ◽  
Emilie Belley-Cote ◽  
...  
Keyword(s):  
Cardiac Surgery ◽  
Red Cell ◽  
Red Cell Transfusion

A MAJORITY OF CARDIAC SURGERY PATIENTS STILL RECEIVE RED CELL TRANSFUSION IN ACADEMIC HEALTH CENTERS

1998 ◽  
Vol 89 (Supplement) ◽  
pp. 1242A
Author(s):  
John F. Butterworth ◽  
Robert L. James ◽  
Richard C. Prielipp ◽  
Richard Creeron ◽  
Julie Cerese
Keyword(s):  
Cardiac Surgery ◽  
Health Centers ◽  
Academic Health Centers ◽  
Red Cell ◽  
Academic Health ◽  
Red Cell Transfusion

scholarly journals Cardioplegia in paediatric cardiac surgery: a systematic review of randomized controlled trials

2018 ◽  
Vol 28 (1) ◽  
pp. 144-150 ◽  
Author(s):  
Nigel E Drury ◽  
Ivan Yim ◽  
Akshay J Patel ◽  
Nicola K Oswald ◽  
Cher-Rin Chong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cardiac Surgery ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Paediatric Cardiac Surgery
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