Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2021
OBJECTIVES Primary objectives: to compare radial artery occlusion rate (RAO) after cardiac catheterization between catecholamine-chitosan pad (InnoSEAL) and pneumatic compression device (PCD) and to compare difference in hemostasis time and radial monitoring termination time between two arms. Secondary objectives: to compare radial site bleeding and ease of use of two methods by cath-lab technicians. BACKGROUND Hemostatic pads may be an effective alternative to PCD with lesser chance of access site complications with advantage of shortened compression time. METHODS Patients (N = 606) undergoing trans-radial, diagnostic or interventional procedures were randomized to either InnoSEAL arm or PCD. RAO was assessed using US Duplex; performed 6-24 hr posthemostatic device removal. Time to hemostasis was recorded as per defined protocols. Ease of use among cath-lab technicians was assessed through 5 point Likert scale. RESULTS Data of 597 patients was analyzed (299 InnoSEAL, 298 PCD). RAO rate was 8.5% in InnoSEAL and 9.4% in PCD arm (p value >.05). The pooled median hemostasis time and time to termination of radial monitoring was 42 versus 225 min and 50 versus 240 min in InnoSEAL and PCD arms, respectively (p value: <.01). There was no difference in Grade I/II hematoma (InnoSEAL: 1.3% vs. PCD: 3.4%). InnoSEAL was marginally acceptable compared to PCD by technicians. CONCLUSION Hemostasis time is significantly shorter in InnoSEAL arm with reasonable acceptability to its usage among cath lab staff. RAO and bleeding complications are comparable between the arms. Based on our findings, it seems feasible to include Chitosan based hemostasis pad routinely in cath lab.
Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial
American journal of cardiovascular drugs : drugs, devices, and other interventions. 2021
BACKGROUND Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials. OBJECTIVES The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention. METHODS From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year. RESULTS Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001). CONCLUSIONS Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov .
Is there a renoprotective value to leukodepletion during heart valve surgery? A randomized controlled trial (ROLO)
Journal of cardiothoracic surgery. 2021;16(1):58
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.
Continuous postoperative pericardial flushing reduces postoperative bleeding after coronary artery bypass grafting: A randomized trial
BACKGROUND Prolonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent accumulation of blood and clots in the pericardium. We developed the continuous postoperative pericardial flushing (CPPF) therapy to improve wound drainage and reduce postoperative blood loss and bleeding-related complications after cardiac surgery. This study compared CPPF to standard care in patients after coronary artery bypass grafting (CABG). METHODS This is a single center, open label, randomized trial that enrolled patients at the Amsterdam UMC, location AMC, Amsterdam, the Netherlands. The study was registered at the 'Netherlands Trial Register', study identifier NTR5200 . Adults undergoing CABG were randomly assigned to receive CPPF therapy or standard care, participants and investigators were not masked to group assignment. The primary end point was postoperative blood loss in the first 12-hours after surgery. FINDINGS Between the January 15, 2014 and the March 13, 2017, 169 patients were enrolled and assigned to CPPF therapy (study group; n = 83) or standard care (control group; n = 86). CPPF reduced postoperative blood loss when compared to standard care (median differences -385 ml, reduction 76% p=≤0.001), with the remark that these results are overestimated due to a measurement error in part of the study group. None of patients in the study group required reoperation for non-surgical bleeding versus 3 (4%, 95% CI -0.4% to 7.0%) in the control group. None of the patients in the study group suffered from cardiac tamponade, versus 3 (4%, 95% CI -0,4% to 7.0%) in the control group. The incremental cost-effectiveness ratio was €116.513 (95% bootstrap CI €-882.068 to €+897.278). INTERPRETATION The use of CPPF therapy after CABG seems to reduce bleeding and bleeding related complications. With comparable costs and no improvement in Qualty of Life (QoL), cost consideration for the implementation of CPPF is not relevant. None of the patients in the study group required re-interventions for non-surgical bleeding or acute cardiac tamponade, which underlines the proof of concept of this novel therapy. FUNDING This study was funded by ZonMw, the Netherlands organization for health research and development (project 837001405).
Role of Using a Thromboelastometry-Based Protocol for Transfusion Management in Combined Coronary Artery Bypass Grafting and Valve Surgery: A Randomized Clinical Trail
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2021;37(3):422-429
The aim of this study was to evaluate the impact of using a thromboelastometry-based protocol on transfusion requirements in patients undergoing combined coronary artery bypass grafting (CABG) and valve surgery. 80 adult patients scheduled for elective combined CABG and valve surgery were included in this clinical trial study. Patients were randomly allocated to the thromboelastometry (ROTEM) (n = 40) or control groups (n = 40). In the ROTEM group, transfusion was directed according to a thromboelastometry-based protocol. In the control group, transfusion was conducted according to the routine practices including conventional coagulation testing and clinical judgments. Finally, transfusion requirements were compared between groups. Use of thromboelastometry- based protocol resulted in 67% reduction in blood products units' consumption as well as 23% in the percentage of patients transfused. This reduction was especially evident in relation to fresh frozen plasma (FFP) and platelet consumption. No significant differences were found both in the percentage of patients receiving RBC and number of transfused RBC units. Using thromboelastometry tests incorporated a protocol results in reduction of transfusion requirements in patients undergoing elective combined CABG and valve surgery.
Transfusion Strategies for Pediatric Cardiac Surgery: A Meta-Analysis and Trial Sequential Analysis
Pediatric cardiology. 2021
This study aimed to compare the effects of restrictive and liberal red blood cell (RBC) transfusion strategies on pediatric patients undergoing cardiac surgery, including cyanotic and non-cyanotic children. A literature search of the MEDLINE, EMBASE, PubMed, and the Cochrane Library database was conducted. Meta-analyses were carried out comparing restrictive and liberal transfusion strategies. Subgroup analyses were performed based on the basis of cyanotic status. Five randomized controlled trials with a total of 497 children were included. There was no significant difference in the risk of in-hospital mortality between the two transfusion strategies (risk ratio 1.21; 95% confidence interval 0.49 to 2.99; P = 0.68). The trial sequential analysis suggested that the current meta-analysis had an absence of evidence for in-hospital mortality, and the data were insufficient. Moreover, no significant differences existed between groups in terms of risk of infection, blood loss, duration of mechanical ventilation, pediatric intensive care unit (PICU) stay duration, or hospital stay duration. Cyanotic children treated with a liberal transfusion strategy had a shorter ventilator duration, but the transfusion strategy did not affect in-hospital mortality, infection, hospital stay, or PICU stay duration. On the basis of the available data, our analysis indicates that a liberal transfusion strategy did not lead to a better outcomes, but the data are extremely sparse, which highlights the need for clearer transfusion guidelines specific to this specific population.Trial registration number CRD42018102283.
Is a fixed low-dose protamine better at reducing postoperative bleeding in off pump coronary artery bypass grafting?
Asian cardiovascular & thoracic annals. 2021;:218492321997393
CONTEXT Protamine is used ubiquitously in all cardiac surgeries for reversal of heparin. Risk of postoperative bleeding is increased with inadequate heparin reversal or due to anticoagulant side effects of protamine; hence, it is important to dose protamine properly. This study compares 80% protamine dose with full dose on postoperative bleeding and transfusion needs in OPCAB. AIMS The aim of our study was to find whether lower dose of protamine could reduce postoperative bleeding and need for blood product transfusions in off pump coronary artery bypass grafting as compared to the regular dose of protamine. SETTINGS AND DESIGN This was a double-blinded randomised controlled trial where patients posted for off pump CABG meeting the inclusion criteria were included in the study. METHODS AND MATERIAL Ninety patients were randomised to two groups, group F receiving full dose of protamine of 1 mg per mg heparin used, and group L received 0.8 mg per mg. Postoperative activated clotting time, bleeding at 1 h, 4 h, 24 h and total drainage till drains removal and blood product transfusion requirements were noted.Statistical analysis used: SPSS software. RESULTS Both groups were matched in demographics, preoperative cessation of heparin and aspirin and platelet counts. Both groups received equal heparin dose, activated clotting time before protamine, activated clotting time post protamine in OT and ICU were equal as were the conduits used. There was no significant difference between the groups in post-operative drainage over time or in the need for blood product transfusions. CONCLUSIONS Eighty per cent of the dose of protamine can adequately reverse the heparin used during off pump cardiac surgery without any increase in incidence of postoperative bleeding or need for blood product transfusions.
Modified ultrafiltration reduces postoperative blood loss and transfusions in adult cardiac surgery: a meta-analysis of randomized controlled trials
Interactive cardiovascular and thoracic surgery. 2021
OBJECTIVES Cardiopulmonary bypass in cardiac surgery has been associated with several deleterious effects including haemodilution and systemic inflammation. Modified ultrafiltration (MUF) has been well established in paediatric cardiac surgery in counteracting postperfusion syndrome. However, MUF is less commonly used in adult cardiac surgery. In this meta-analysis, we compared clinical outcomes in adult patients who underwent cardiopulmonary bypass with and without MUF. METHODS Electronic searches were performed using Pubmed, Ovid Medline, EMBASE and the Cochrane Library until April 2020. Selection criteria were randomized studies of adult cardiac surgery patients comparing MUF versus no MUF. Primary outcomes were postoperative mortality, haematocrit, blood transfusion, chest tube drainage, duration of intensive care unit (ICU) stay and duration of mechanical ventilation. RESULTS Thirteen randomized controlled trials were included, comprising 626 patients in the MUF group, and 610 patients in the control (no-MUF) group. There was a significantly improved postoperative haematocrit [mean difference 2.70, 95% confidence interval (CI) 0.68-4.73, P = 0.009], lower chest tube drainage (mean difference -105 ml, 95% CI -202 to -7 ml, P = 0.032), lower postoperative blood transfusion rate (mean difference -0.73 units, 95% CI -0.98 to -0.47 units, P < 0.0001) and shorter duration of ICU stay (mean difference -0.13 days, 95% CI -0.27 to -0.00 days, P = 0.048) in the MUF group. There was no difference in ventilation time (mean difference -0.47 h, 95% CI -2.05 to 1.12 h, P = 0.56) or mortality rates (odds ratio 0.62, 95% CI 0.28-1.33, P = 0.22). There were no reported complications associated with MUF. CONCLUSIONS MUF is a safe and feasible option in adult cardiac patients, with significant benefits including improved postoperative haematocrit, as well as reduced postoperative chest tube bleeding, transfusion requirements and duration of ICU stay.
Comparison of the in-vivo effect of two tranexamic acid doses on fibrinolysis parameters in adults undergoing valvular cardiac surgery with cardiopulmonary bypass - a pilot investigation
BMC anesthesiology. 2021;21(1):33
BACKGROUND The blood saving efficacy of TXA in cardiac surgery has been proved in several studies, but TXA dosing regimens were varied in those studies. Therefore, we performed this study to investigate if there is a dose dependent in-vivo effect of TXA on fibrinolysis parameters by measurement of fibrinolysis markers in adults undergoing cardiac surgery with CPB. METHODS A double-blind, randomized, controlled prospective trial was conducted from February 11, 2017 to May 05, 2017. Thirty patients undergoing cardiac valve surgery were identified and randomly divided into a placebo group, low-dose group and high-dose group by 1: 1: 1. Fibrinolysis parameters were measured by plasma levels of D-Dimers, plasminogen activator inhibitor-1 (PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI), plasmin-antiplasmin complex (PAP), tissue plasminogen activator (tPA) and thrombomodulin (TM). Those proteins were measured at five different sample times: preoperatively before the TXA injection (T(1)), 5 min after the TXA bolus (T(2)), 5 min after the initiation of CPB (T(3)), 5 min before the end of CPB (T(4)) and 5 min after the protamine administration (T(5)). A Thrombelastography (TEG) and standard coagulation test were also performed. RESULTS Compared with the control group, the level of the D-Dimers decreased in the low-dose and high-dose groups when the patients arrived at the ICU and on the first postoperative morning. Over time, the concentrations of PAI-1, TAFI, and TM, but not PAP and tPA, showed significant differences between the three groups (P < 0.05). Compared with the placebo group, the plasma concentrations of PAI-1 and TAFI decreased significantly at the T3 and T4 (P < 0.05); TAFI concentrations also decreased at the T5 in low-dose group (P < 0.05). Compared with the low-dose group, the concentration of TM increased significantly at the T4 in high-dose group. CONCLUSIONS The in-vivo effect of low dose TXA is equivalent to high dose TXA on fibrinolysis parameters in adults with a low bleeding risk undergoing valvular cardiac surgery with cardiopulmonary bypass, and a low dose TXA regimen might be equivalent to high dose TXA for those patients. TRIAL REGISTRATION ChiCTR-IPR-17010303 , Principal investigator: Zhen-feng ZHOU, Date of registration: January 1, 2017.
Preradiosurgery embolization in reducing the postoperative hemorrhage rate for patients with cerebral arteriovenous malformations: a systematic review and meta-analysis
Neurosurgical review. 2021
Few studies have examined the postoperative hemorrhage rate of cerebral arteriovenous malformations (AVMs) treated by embolization prior to stereotactic radiosurgery. The objective of this analysis was to compare the postoperative hemorrhage rate between AVMs treated with and those treated without preradiosurgery embolization. A systematic search of the PubMed and Embase databases was performed with no restriction on the publication period. Based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies with sufficient baseline and outcome data. The analysis was performed using Comprehensive Meta-Analysis (CMA) 2.0. Eleven studies comprising 2591 patients were eligible for analysis. There was no significant difference in the postoperative hemorrhage rate between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.140, 95% CI 0.851-1.526, p = 0.38). The obliteration rate was significantly lower in the E + SRS group than in the SRS group (OR 0.586, 95% CI 0.398-0.863, p = 0.007). No significant difference in permanent neurological deficits was identified between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.175, 95% CI 0.626-2.206, p = 0.616). Available data suggested that preradiosurgery embolization did not reduce the postoperative hemorrhage rate and resulted in a significantly lower obliteration rate than treatment with SRS alone.