Intravenous iron supplementation treats anemia and reduces blood transfusion requirements in patients undergoing coronary artery bypass grafting-A prospective randomized trial
Annals of cardiac anaesthesia. 2022;25(2):141-147
STUDY OBJECTIVE Preoperative anemia results in two- to sixfold increased incidence of perioperative blood transfusion requirements and reduced postoperative hemoglobin (Hb) level. This prospective study was designed to investigate the effect of preoperative intravenous infusion of iron on Hb levels, blood transfusion requirements, and incidence of postoperative adverse events in patients undergoing coronary artery bypass grafting. DESIGN Prospective randomized trial. SETTING Academic university hospital. PATIENTS Eighty patients (52-67 years old) underwent coronary artery bypass grafting and received either iron therapy or saline infusion preoperatively. INTERVENTIONS Patients were randomly allocated to iron or placebo groups. In the iron group, patients received a single intravenous dose of ferric carboxymaltose (1000 mg in 100 mL saline) infused slowly over 15 min 7 days before surgery. In placebo group, patients received a single intravenous dose of saline (100 mL saline) infused slowly over 15 min 7 days before surgery. MEASUREMENTS Patients were followed up with regards to incidence of anemia, Hb level on admission, preoperatively, postoperatively, 1 week and 4 weeks after discharge, aortic cross-clamp time, the number of packed red blood cells (pRBCs) units, the percentage of reticulocytes pre-postoperatively and 1 week later, hospital stay and intensive care unit (ICU) stay length, and the incidence of postoperative complications. MAIN RESULTS Iron therapy was associated with lower incidence of anemia 4 weeks after discharge (P < 0.001). Hb level was significantly higher in the iron group compared to the placebo group preoperatively and postoperatively, and 4 weeks after discharge (P < 0.001). Iron therapy resulted in shorter hospital and ICU stay (P < 0.001) and shorter aortic cross-clamp time, reduced pRBCs requirements postoperatively. Percentage of reticulocytes was significantly higher in placebo group than in iron group postoperatively and 1 week after discharge and the incidence of postoperative complications was similar to the placebo group. CONCLUSIONS Preoperative IV iron infusion is a safe and feasible way to manage preoperative anemia. Preoperative administration of IV iron is associated with a higher postoperative Hb level, shorter hospital and ICU stay, and reduced perioperative red blood cell transfusion requirements with insignificant difference in incidence of postoperative complications.
Whole Blood Adsorber During CPB and Need for Vasoactive Treatment After Valve Surgery in Acute Endocarditis: A Randomized Controlled Study
Journal of cardiothoracic and vascular anesthesia. 2022
OBJECTIVES Patients with endocarditis requiring urgent valvular surgery with cardiopulmonary bypass are at a high risk of developing systemic inflammatory response syndrome and septic shock, necessitating intensive use of vasopressors after surgery. The use of a cytokine hemoadsorber (CytoSorb, CytoSorbents Europe GmbH, Germany) during cardiac surgery has been suggested to reduce the risk of inflammatory activation. The study authors hypothesized that adding a cytokine adsorber would reduce cytokine burden, which would translate into improved hemodynamic stability. DESIGN A randomized, controlled, nonblinded clinical trial. SETTING At a university hospital, tertiary referral center. PARTICIPANTS Nineteen patients with endocarditis undergoing valve surgery. INTERVENTION A cytokine hemoadsorber integrated into the cardiopulmonary bypass circuit. MEASUREMENTS AND MAIN RESULTS The accumulated norepinephrine dose in the intervention group was half or less at all postoperative time points compared to the control group, although it did not reach statistical significance; at 24 and 48 hours (median 36 [25-75 percentiles; 12-57] μg v 114 [25-559] μg, p = 0.11 and 36 [12-99] μg v 261 [25-689] μg, p = 0.09). There was no significant difference in chest tube output, but there was a significantly lower need for the transfusion of red blood cells (285 [0-657] mL v 1,940 [883-2,148] mL, p = 0.03). CONCLUSIONS There was no statistically significant difference between the groups with regard to vasopressor use after surgery for endocarditis with the use of a cytokine hemoadsorber during cardiopulmonary bypass. Additional, larger randomized controlled trials are needed to definitely assess the potential effect.
A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery: The cryopreserved versus liquid platelet-New Zealand pilot trial
Vox sanguinis. 2022;117(3):337-345
BACKGROUND AND OBJECTIVES Platelets for transfusion have a shelf-life of 7 days, limiting availability and leading to wastage. Cryopreservation at -80°C extends shelf-life to at least 1 year, but safety and effectiveness are uncertain. MATERIALS AND METHODS This single centre blinded pilot trial enrolled adult cardiac surgery patients who were at high risk of platelet transfusion. If treating clinicians determined platelet transfusion was required, up to three units of either cryopreserved or liquid-stored platelets intraoperatively or during intensive care unit admission were administered. The primary outcome was protocol safety and feasibility. RESULTS Over 13 months, 89 patients were randomized, 23 (25.8%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 h between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 10(3) /μl vs. 157 × 10(3) /μl, median difference 39.5 ×10(3) /μl, p = 0.03). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24-h blood loss, red cell transfusion or a composite bleeding outcome. CONCLUSION This pilot randomized controlled trial demonstrated the feasibility of the protocol and adds to accumulating data supporting the safety of this intervention. Given the clear advantage of prolonged shelf-life, particularly for regional hospitals in New Zealand, a definitive non-inferiority phase III trial is warranted.
Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial
JACC. Cardiovascular interventions. 2022;15(8):810-819
OBJECTIVES The aim of this trial was to test whether the potassium ferrate hemostatic patch (PFHP) as an adjunct to the TR Band (TRB) facilitated an early deflation protocol. BACKGROUND Shorter TRB compression times may reduce the rate of radial artery occlusion (RAO) and reduce observation time after transradial access. METHODS A total of 443 patients were randomized to the TRB or PFHP + TRB, with complete TRB deflation attempted 60 minutes postprocedure. The primary outcome was the time to successful full deflation of the TRB without bleeding, with secondary outcomes of time to discharge and complications including hematoma, RAO, or bleeding requiring intervention beyond TRB reinflation. RESULTS Time to complete TRB deflation was 66 ± 14 minutes with the PFHP vs 113 ± 56 minutes for the TRB alone (P < 0.001). Minor rebleeding requiring TRB reinflation was much more frequent without the PFHP (0% vs 67.7%; P < 0.001) with 2.3 ± 1.3 additional reinflation and deflation attempts needed for hemostasis. Hematomas developed in 4.0% of the PFHP group and 6.8% of the TRB group (P = 0.20). RAO was rare (<1%), although 41% of patients received <5,000 U heparin. Among percutaneous coronary intervention patients, time to TRB deflation (68 ± 15 minutes vs 138 ± 62 minutes; P < 0.001) and composite complications (10.0% vs 24.2%; P = 0.04) were reduced with the PFHP. CONCLUSIONS Compared with the TRB alone, the PFHP facilitated early 60-minute TRB deflation following transradial catheterization, with a numeric reduction in vascular complications. RAO occurs rarely with early deflation regardless of heparin dose. (Comparing TR Band to StatSeal in Conjunction With TR Band II [StatSeal II]; NCT04046952).
Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography
JACC. Cardiovascular interventions. 2022;15(10):1022-1029
OBJECTIVES The main objective of this study was to compare the efficacy of 3 hemostatic methods for the prevention of early radial artery occlusion (RAO): standard patent hemostasis, patent hemostasis with ulnar compression or the ulnar artery transient compression facilitating radial artery patent hemostasis (ULTRA) method, and facilitated hemostasis with a hemostatic disc. BACKGROUND There are no prospective randomized studies that compare early RAO rates with the 3 most used nonocclusive hemostatic methods. METHODS This was a prospective, longitudinal, comparative, and randomized study. The final population analyzed was 1,469, and they were randomized into 3 groups: 491 patients in group 1 with standard patent hemostasis, 490 patients in group 2 with the ULTRA method, and 488 patients in group 3 with facilitated hemostasis with a hemostatic disc. RESULTS The RAO rate at 24 hours of the total population analyzed was 4.6%. By hemostasis groups, it was 3.6% for patent hemostasis, 5.5% for the ULTRA method, and 4.7% for facilitated hemostasis with a hemostatic disc, with no statistical difference among the 3 groups (P = 0.387). At 30 days, the overall rate of RAO was 1.8%, and by groups, it was 1.4% for the patent hemostasis group, 1.8% for the ULTRA method group, and 2.2% for the facilitated hemostasis with a hemostatic disc group, respectively (P = 0.185). CONCLUSIONS The rates of RAO at 24 hours evaluated by plethysmography oximetry and confirmed by ultrasound among 3 current radial hemostasis methods (ie, patent hemostasis, the ULTRA method, and facilitated hemostasis with a hemostatic disc) are not different.
Autologous red blood cell transfusion does not result in a more profound increase in pulmonary capillary wedge pressure compared to saline in critically ill patients: A randomized crossover trial
Vox sanguinis. 2022
BACKGROUND AND OBJECTIVES Transfusion-associated circulatory overload (TACO) is a major cause of severe transfusion-related morbidity. Transfusion of red blood cells (RBCs) has been shown to induce hydrostatic pressure overload. It is unclear which product-specific factors contribute. We set out to determine the effect of autologous RBC transfusion versus saline on pulmonary capillary wedge pressure (PCWP) change. MATERIALS AND METHODS In a randomized crossover trial, patients who had undergone coronary bypass surgery were allocated to treatment post-operatively in the intensive care unit with either an initial 300 ml autologous RBC transfusion (salvaged during surgery) or 300 ml saline infusion first, followed by the other. Primary outcome was the difference in PCWP change. Secondary outcome measures were the difference in extra-vascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI). RESULTS Change in PCWP was not higher after autologous RBC transfusion compared to saline (ΔPCWP 0.3 ± 0.4 vs. 0.1 ± 0.4 mmHg). ΔEVLWI and ΔPVPI were significantly decreased after autologous RBC transfusion compared to saline (ΔEVLWI -1.6 ± 0.6 vs. 0.2 ± 0.4, p = 0.02; ΔPVPI -0.3 ± 0.1 vs. 0.0 ± 0.1, p = 0.01). Haemodynamic variables and colloid osmotic pressure were not different for autologous RBC transfusion versus saline. CONCLUSION Transfusion of autologous RBCs did not result in a more profound increase in PCWP compared to saline. RBC transfusion resulted in a decrease of EVLWI and PVPI compared to saline. Our data suggest that transfusing autologous RBCs may lead to less pulmonary oedema compared to saline. Future studies with allogeneic RBCs are needed to investigate other factors that may mediate the increase of PCWP, resulting in TACO.
Patients undergoing coronary bypass surgery (n= 16).
Autologous red blood cells (RBCs) transfusion, with a subsequent infusion of saline (RBCs: Saline, n= 8).
Saline infusion with a subsequent transfusion of RBCs (Saline: RBCs, n= 8).
The primary outcome was the difference in pulmonary capillary wedge pressure (PCWP) before and after transfusion (ΔPCWP). Secondary outcome measures were the difference in extra-vascular lung water index (EVLWI) and pulmonary vascular permeability index (PVPI). Change in PCWP was not higher after autologous RBCs transfusion compared to saline (ΔPCWP 0.3 ± 0.4 vs. 0.1 ± 0.4 mmHg). ΔEVLWI and ΔPVPI were significantly decreased after autologous RBCs transfusion compared to saline (ΔEVLWI -1.6 ± 0.6 vs. 0.2 ± 0.4; ΔPVPI -0.3 ± 0.1 vs. 0.0 ± 0.1). Haemodynamic variables and colloid osmotic pressure were not different for autologous RBCs transfusion versus saline.
Comparison of Application Effects of Different Hemostasis Methods After Ischemic Cerebrovascular Intervention
Frontiers in surgery. 2022;9:850139
OBJECTIVE To explore the effects of two different hemostasis methods, namely, arterial compression devices and vascular closure devices, in the ischemic cerebrovascular intervention to provide a theoretical basis for clinical selection of hemostasis methods. METHODS A total of 302 patients who underwent ischemic cerebrovascular intervention in our hospital from January 2016 to December 2020 were selected as the research subjects and randomly divided into the control group (n = 151) and the observation group (n = 151). The patients in both groups underwent cerebrovascular intervention. The patients in the control group were treated with an artery compressor for hemostasis after the operation, while those in the observation group were treated with vascular closure devices for hemostasis. The hemostatic indexes and vascular parameters at the puncture site before and after the operation were compared between the two groups. The comfort level of the patients was assessed at 6, 12, and 24 h after the operation with the Kolcaba Comfort Scale score, and the postoperative complications were recorded. RESULTS There was no significant difference in the success rate of hemostasis between the two groups (p > 0.05). The hemostatic time and immobilization time of (2.69 ± 0.62) min and (4.82 ± 0.93) h in the observation group were lower than those in the control group with (16.24 ± 3.58) min and (7.94 ± 1.86) h (p < 0.05). The differences in the minimum inner diameter of the puncture site and its nearby vessels and the peak velocity of blood flow between the two groups before and after the operation were not statistically significant within or between groups (p > 0.05). The scores of the Kolcaba comfort scale in the observation group (80.16 ± 8.49) and (93.65 ± 9.26) at 6 and 12 h, respectively, after the operation, were higher than those in the control groups (72.08 ± 7.54) and (85.49 ± 8.63) (p < 0.05). The 24 h postoperative Kolcaba comfort scale score was (97.54 ± 9.86) in the observation group and (96.82 ± 9.64) in the control group, and the difference was not statistically significant (p > 0.05). In the control group, there were 7 cases of dysuria, 12 cases of low back pain, 14 cases of sleep disorder, 20 cases of mental stress, and 5 cases of wound bleeding, and the total incidence of complications was 38.41% (58/151). In the observation group, there were 4 cases of dysuria, 8 cases of low back pain, 10 cases of sleep disorder, 14 cases of mental stress, and 3 cases of wound bleeding, and the total incidence of complications was 25.83% (39/151). The total incidence of complications in the observation group was lower than that in the control group (p < 0.05). CONCLUSION For patients with ischemic cerebrovascular disease undergoing femoral artery puncture intervention, the use of vascular closure devices can stop the bleeding quickly, which can significantly shorten the bleeding time, and the postoperative braking time of patients is short, with high comfort and fewer complications.
Systematic review on transcaval embolization for type II endoleak after endovascular aortic aneurysm repair
Journal of vascular surgery. 2022
INTRODUCTION Persistent endoleak type II (ET II) after endovascular repair for aortic aneurysms is not always a begin condition and has been associated to sac expansion, rupture and re-intervention. A variety of different endovascular approaches are available for ET II treatment. The aim of this systematic review was to assess the currently available literature on transcaval embolization in ET II treatment after standard or complex endovascular aortic aneurysm repair. METHODS This systematic review protocol was registered to the PROSPERO (CRD42021289686). The Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement (PRISMA) guidelines and P.I.C.O. model was followed. A data search of the literature was conducted, using PubMed, EMBASE via Ovid and CENTRAL databases, until September 30, 2021. Only studies reporting on ET II embolization using the transcaval approach after endovascular aneurysm repair were included. Studies reporting on different type of endoleak treatment or other embolization approach were excluded. The quality of studies was assessed using the Newcastle-Ottawa Scale (NOS). Primary outcomes were technical success and freedom from ET II persistence during follow-up while secondary were any post-operative complication associated to transcaval embolization and need for re-intervention. RESULTS The search yielded 2,861 manuscripts in total. Eight manuscripts were included, reporting on 117 patients and 128 transcaval embolizations. The indication for treatment was ET II presence with sac expansion >5mm while in two studies the presence of persistent endoleak has set the indication to intervene. The technical success was 91.4% (117/128) while a variety of embolic materials were used including coils, thrombin, and glue. Three cases of deep vein thrombosis were recorded while the remaining morbidity and mortality were null. Follow-up was ranging between 0-25 months. Out of eight studies, persistent ET II rate was 12.8% and 18 re-interventions were performed (14.1%,); including ten transcaval coil embolizations (56%). Sac expansion was reported in 11 cases out of 3 studies (17%). Only one case of death, not associated to transcaval embolization, was recorded. CONCLUSIONS Transcaval embolization for ET II treatment presents a high technical success and low mortality in the early and mid-term period. The ET II persistence rate is low during the available 12-month follow-up.
Randomised open-label trial comparing intravenous iron and an erythropoiesis-stimulating agent versus oral iron to treat preoperative anaemia in cardiac surgery (INITIATE trial)
British journal of anaesthesia. 2022
BACKGROUND Preoperative anaemia is a risk factor for adverse postoperative outcomes after cardiac surgery. Iron deficiency is a frequent cause of low preoperative haemoglobin. An effective treatment for preoperative anaemia associated with iron deficiency has not been determined. METHODS We conducted a single-centre, open-label, pragmatic randomised trial, enrolling 156 elective cardiac surgery patients who had low preoperative haemoglobin (100-130 g L(-1)) with iron deficiency (serum ferritin <100 μg L(-1) or transferrin saturation <30%) to compare intravenous ferric derisomaltose 1000 mg and darbepoetin 200 μg subcutaneously (intervention group) with oral ferrous sulphate 600 mg daily (control group). The primary outcome was transfusion of at least one unit of allogeneic red cells during surgery and within the following 5 days. Secondary outcomes included the change in haemoglobin concentration between randomisation and surgery, red cell transfusion volume, postoperative blood loss, pre-specified postoperative complications, length of hospital stay, and in-hospital death. RESULTS The odds of red cell transfusion were lower in the intervention group compared with the control group (adjusted odds ratio=0.33; 95% confidence interval [CI], 0.15-0.75; P=0.008). Of the secondary outcomes, the only significant difference was the increase in haemoglobin between randomisation and surgery, intervention vs control 9.5 g L(-1) (95% CI, 6.8-12.2; P<0.001). CONCLUSIONS In patients with a low preoperative haemoglobin and iron deficiency, preoperative treatment with a single dose of ferric derisomaltose and darbepoetin decreased the proportion of participants who received a perioperative blood transfusion as a consequence of a greater increase in haemoglobin compared with treatment with oral ferrous sulphate. CLINICAL TRIAL REGISTRATION ISRCTN Number: 41421863; EUDRACT number: 2011-003695-36.
A Meta-Analysis of Using Protamine for Reducing the Risk of Hemorrhage During Carotid Recanalization: Direct Comparisons of Post-operative Complications
Frontiers in pharmacology. 2022;13:796329
Background: Protamine can decrease the risk of hemorrhage during carotid recanalization. However, it may cause severe side effects. There is no consensus on the safety and efficacy of protamine during surgery. Thus, we conduct a comprehensive review and meta-analysis to compare the differences between the protamine and the no-protamine group. Method: We systematically obtained literature from Medline, Google Scholar, Cochrane Library, and PubMed electronic databases. All four databases were scanned from 1937 when protamine was first adopted as a heparin antagonist until February 2021. The reference lists of identified studies were manually checked to determine other eligible studies that qualify. The articles were included in this meta-analysis as long as they met the criteria of PICOS; conference or commentary articles, letters, case report or series, and animal observation were excluded from this study. The Newcastle-Ottawa Quality Assessment Scale and Cochrane Collaboration's tool are used to assess the risk of bias of each included observational study and RCT, respectively. Stata version 12.0 statistical software (StataCorp LP, College Station, Texas) was adopted as statistical software. When I (2) < 50%, we consider that the data have no obvious heterogeneity, and we conduct a meta-analysis using the fixed-effect model. Otherwise, the random-effect model was performed. Result: A total of 11 studies, consisting of 94,618 participants, are included in this study. Our analysis found that the rate of wound hematoma had a significant difference among protamine and no-protamine patients (OR = 0.268, 95% CI = 0.093 to 0.774, p = 0.015). Furthermore, the incidence of hematoma requiring re-operation (0.7%) was significantly lower than that of patients without protamine (1.8%). However, there was no significant difference in the incidence of stroke, wound hematoma with hypertension, transient ischemic attacks (TIA), myocardial infarction (MI), and death. Conclusion: Among included participants undergoing recanalization, the use of protamine is effective in reducing hematoma without increasing the risk of having other complications. Besides, more evidence-based performance is needed to supplement this opinion due to inherent limitations.