Total Heparin Dose Research Articles

Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial

The current guidelines for acute coronary syndrome (ACS) discourage the use of anticoagulation after percutaneous coronary intervention (PCI) without specific indications, although the recommendation is not well supported by evidence. In this post hoc analysis of the ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 (STOPDAPT-3) trial, 30-day outcomes were compared between the 2 groups with and without post-PCI heparin administration among patients with ACS who did not receive mechanical support devices. The co-primary end points were the bleeding end point, defined as the Bleeding Academic Research Consortium type 3 or 5 bleeding, and the cardiovascular end point, defined as a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke. Among 4,088 patients with ACS, 2,339 patients (57.2%) received post-PCI heparin. The proportion of patients receiving post-PCI heparin was higher among those with ST-elevation myocardial infarction compared with others (72.3% and 38.8%, p <0.001), and among patients with intraprocedural adverse angiographic findings compared with those without (67.6% and 47.5%, p <0.001). Post-PCI heparin compared with no post-PCI heparin was associated with a significantly increased risk of the bleeding end point (4.75% and 2.52%, adjusted hazard ratio 1.69, 95% confidence interval 1.15 to 2.46, p = 0.007) and a numerically increased risk of the cardiovascular end point (3.16% and 1.72%, adjusted hazard ratio 1.56, 95% confidence interval 0.98 to 2.46, p = 0.06). Higher hourly dose or total doses of heparin were also associated with higher incidence of both bleeding and cardiovascular events within 30 days. In conclusion, post-PCI anticoagulation with unfractionated heparin was frequently implemented in patients with ACS. Post-PCI heparin use was associated with harm in terms of increased bleeding without the benefit of reducing cardiovascular events. Trial identifier: STOPDAPT-3 ClinicalTrials.gov number, NCT04609111.

Comparison of Blood Concentration and Weight-Based Heparin and Protamine Dosing Strategies for Cardiopulmonary Bypass: A Systematic Review and Meta-Analysis.

The conventional method of heparin and protamine management during cardiopulmonary bypass (CPB) is based on total body weightwhich fails to account for the heterogeneous response to heparinin each patient. On the other hand, the literature is inconclusive on whether individualized anticoagulation management based on real-time blood heparin concentration improves post-CBP outcomes. We searched databases of Medline, Excerpta Medica dataBASE (EMBASE), PubMed, Cumulative Index to Nursing and Allied Health Literature (CINHL), and Google Scholar, recruiting randomized controlled trials (RCTs) and prospective studies comparing the outcomes of dosing heparinand/or protamine based on measured heparin concentration versus patient'stotal body weightfor CPB.Random effects meta-analyses and meta-regression were conducted to compare the outcome profiles. Primary endpoints include postoperative blood loss and the correlation with heparin and protamine doses, the reversal protamine and loading heparin dose ratio; secondary endpoints included postoperative platelet counts, antithrombin III, fibrinogen levels, activated prothrombin time (aPTT), incidences of heparin rebound, and re-exploration of chest wound for bleeding. Twenty-six studies, including 22 RCTs and four prospective cohort studies involving 3,810 patients, were included.Compared to body weight-based dosing, patients of individualized, heparin concentration-based group had significantly lower postoperative blood loss (mean difference (MD)=49.51mL, 95% confidence interval (CI): 5.33-93.71), lower protamine-to-heparin dosing ratio (MD=-0.20, 95% CI: -0.32~ -0.12), and higher early postoperative platelet counts (MD=8.83, 95% CI: 2.07-15.59). The total heparin doses and protamine reversal were identified as predictors of postoperative blood loss by meta-regression. There was a significant correlation between the doses of heparin and protamine with postoperative blood loss; therefore, précised dosing of both could be critical for reducingbleeding and transfusion requirements. Data from the enrolled studies indicated that compared to conventional weight-based dosing, individualized, blood concentration-based heparin and protamine dosing may have outcome benefits reducing postoperative blood loss.The dosing calculation of heparin based on the assumption of a one-compartment pharmacokinetic/pharmacodynamic (PK/PD) model and linear relationship between the calculated dose and blood heparin concentration may be inaccurate.With the recent advancement of the technologies of machine learning, individualized, precision management of anticoagulation for CPB may be possible in the near future.

Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study.

Individualized heparin and protamine management is increasingly used as a strategy to reduce coagulation activation and bleeding complications. While it is associated with increased heparin requirements during Cardiopulmonary Bypass (CPB), the impact on protamine administration remains controversial. We aim to investigate the effect of heparin level-guided monitoring on protamine dosing during cardiac surgery where low-anticoagulation protocols are implemented. This is a prospective, randomized, controlled trial. A total of 132 patients undergoing elective full-spectrum cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC) were recruited. All patients were managed by the same anaesthetic, surgical and perfusion team. Patients were randomly allocated in two groups; the individualized heparin-protamine titration (IHPT) group and the conventional heparinization and reversal group by using ACT (cACT) with a 0.75:1, protamine: heparin ratio. Titration was accomplished with the Hepcon HMS Plus (Medtronic, Minneapolis, MN) system. The primary outcome of the study was the total protamine dose used. Secondary outcomes comprised of the total heparin dose, the percentage of patients achieving target ACT, 24-h transfusion requirements, postoperative bleeding, duration of mechanical ventilation, major morbidity and length of hospital stay. Patients in each group were divided in two subgroups according to the target ACT; those operated for coronary artery bypass grafting (CABG) using a target ACT >300s and the rest (non-CABG) patients operated with a target ACT >400s, respectively. Protamine requirements were significantly reduced when IHPT was implemented; CABG (118 ± 24mg vs 163 ± 61 mg; p < 0.001) and non-CABG cases (151 ± 46mg vs 197 ± 45mg; p < 0.001). Moreover, heparin requirements were significantly higher in the non-CABG subgroup managed with IHPT (34,539 ± 7658 IU vs 29,893 ± 9037 IU; p = 0.02). In overall, no significant differences were detected with respect to postoperative bleeding, transfusion of RBC or other blood products. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery with MiECC implementing reduced anticoagulation strategy. clinicaltrials.gov; NCT04215588.

Defining heparin resistance: communication from the ISTH SSC Subcommittee of Perioperative and Critical Care Thrombosis and Hemostasis

The term heparin resistance (HR) is used by clinicians without specific criteria. We performed a literature search and surveyed our SSC membership to better define the term when applied to medical and intensive care unit patients. The most common heparin dosing strategy reported in the literature (53%) and by survey respondents (80.4%) was the use of weight-based dosing. Heparin monitoring results were similar based on the proportion of publications and respondents that reported the use of anti-Xa and activated partial thromboplastin time. The most common literature definition of HR was >35 000 U/d, but no consensus was reported among survey respondents regarding weight-based and the total dose of heparin when determining resistance. Respondent consensus on treating HR included antithrombin supplementation, direct thrombin inhibitors, or administering more heparin as the strategies available for treating HR. A range of definitions for HR exist. Given the common use of heparin weight-based dosing, future publications employing the term HR should include weight-based definitions, monitoring assay, and target level used. Further work is needed to develop a consensus for defining HR.

Can the Minimum Protamine Dose to Neutralize Heparin at the Completion of Cardiopulmonary Bypass be Significantly Lower than the Conventional Practice?

Systemic anticoagulation with heparin during cardiopulmonary bypass (CPB) should be neutralized by protamine administration to restore normal hemostasis. However, protamine has potentially serious side effects and excessive protamine can cause increased postoperative bleeding. Thus, our goal is to appropriately dose protamine at the completion of CPB to neutralize heparin so that neither residual heparin nor excessive protamine is present. We performed a retrospective study of 216 patients who underwent cardiac surgery to search for a safe minimum protamine dose (PD) when measuring heparin concentration (HC). In addition, we developed a formula to determine PD using total heparin dose (THD) and CPB time without measuring HC. When protamine-to-heparin ratio (P-to-H) is set at 1 mg protamine to 100 international unit (IU) heparin in HMS Plus Hemostasis Management System (HMS), we determined that 75% of the calculated total PD is a safe minimum PD to sufficiently neutralize circulating heparin after CPB. On average, this translates into either .37 mg protamine/100 IU heparin of THD or .54 mg/100 IU of the first heparin bolus. The formula we developed to calculate PD without measuring HC can provide a PD that strongly agrees with the safe minimum PD when measuring HC. The safe minimum PD to neutralize circulating heparin after CPB can be significantly lower than conventional dosing practices. Reduction of PD may decrease the risk of postoperative bleeding and protamine-related adverse events. Based on our data, we decreased P-to-H in HMS to examine whether it is possible to reduce PD further than the safe minimum PD determined in this study.

Can the Minimum Protamine Dose to Neutralize Heparin at the Completion of Cardiopulmonary Bypass be Significantly Lower than the Conventional Practice?

Systemic anticoagulation with heparin during cardiopulmonary bypass (CPB) should be neutralized by protamine administration to restore normal hemostasis. However, protamine has potentially serious side effects and excessive protamine can cause increased postoperative bleeding. Thus, our goal is to appropriately dose protamine at the completion of CPB to neutralize heparin so that neither residual heparin nor excessive protamine is present. We performed a retrospective study of 216 patients who underwent cardiac surgery to search for a safe minimum protamine dose (PD) when measuring heparin concentration (HC). In addition, we developed a formula to determine PD using total heparin dose (THD) and CPB time without measuring HC. When protamine-to-heparin ratio (P-to-H) is set at 1 mg protamine to 100 international unit (IU) heparin in HMS Plus Hemostasis Management System (HMS), we determined that 75% of the calculated total PD is a safe minimum PD to sufficiently neutralize circulating heparin after CPB. On average, this translates into either .37 mg protamine/100 IU heparin of THD or .54 mg/100 IU of the first heparin bolus. The formula we developed to calculate PD without measuring HC can provide a PD that strongly agrees with the safe minimum PD when measuring HC. The safe minimum PD to neutralize circulating heparin after CPB can be significantly lower than conventional dosing practices. Reduction of PD may decrease the risk of postoperative bleeding and protamine-related adverse events. Based on our data, we decreased P-to-H in HMS to examine whether it is possible to reduce PD further than the safe minimum PD determined in this study.

Coronary angioplasty and COVID-19: are heparin requirements and thrombotic complications increasing?

Funding AcknowledgementsType of funding sources: None.BackgroundCovid-19 infection is associated with coagulopathy and possible heparin resistance, raising concerns that routine heparin during percutaneous coronary intervention (PCI) is failing to achieve adequate anticoagulation. We examined heparin requirements and efficacy in patients treated by PCI before and after the first reported UK case of Covid-19 (January 31st 2020).MethodsWe retrospectively compared heparin dose, Activated Clotting Time (ACT) and coronary flow (TIMI grade) for PCI procedures at a London cardiac centre in the 3 months before the UK pandemic and the three months afterwards. Testing for COVID was not routinely performed. Pre-specified analyses in patients with STEMI, NSTEMI and Stable angina were undertaken.ResultsOf 1227 PCI procedures performed over the period of observation, 690 were pre-pandemic and 537 were afterwards. Overall median heparin dose per case was 11000units versus 11500units (p = 0.137) and maximum ACTs were 291s versus 305s, respectively (p = 0.135). Pre-PCI TIMI 3 flow was lower during the pandemic than before (60% v 65%, p = 0.005) but Post-PCI flow was similar (96% versus 96%, p = 0.839). There were no statistically significant differences in heparin dose or achieved ACT among patients with STEMI, NSTEMI or Stable presentations.ConclusionIn spite of the increasing evidence that COVID-19 infection causes thrombosis, it appears that standard heparin management during PCI is sufficient to achieve effective anticoagulation and avoid peri-procedural thrombotic complications. Group 1 Pre PandemicGroup 2 PandemicP valueNumber of doses given3 (3 to 4)3 (3 to 4)0.952Total Heparin dose (units)11000 (8000 to 14000)11500 (9000 to 14000)0.137Number of ACTs measured2 (1 to 2)2 (1 to 2)0.194First ACT (seconds)240 (199 to 318)248 (206 to 326)0.256Maximum ACT (seconds)291 (230 to 368)305 (239 to 369)0.135Heparin dose and Activated Clotting Times (ACT) in patients undergoing PCI before Covid-19 pandemic (Group 1) and during pandemic (Group 2); median and interquartile ranges Figure. Clinical Presentation

Routine fixed-dose heparin vs. ACT-guided heparin administration for elective PCI and its influence on patient in-hospital outcome: a retrospective study.

Activated clotting time (ACT)-based heparin dosing during percutaneous intervention (PCI) is recommended by Society guidelines. However, the relationship between ACT and outcome in the setting of elective PCI has not been sufficiently studied. We sought to evaluate the in-hospital outcome of patients undergoing elective PCI while receiving fixed-dose heparin without ACT measurement versus those with ACT-guided management. This retrospective study included consecutive patients undergoing elective PCI in a single-center between 11/2015 and 12/2018. Patients were divided into two groups, depending on whether ACT was measured. Heparin-only anticoagulation and non-femoral procedures were allowed. Patient demographics, procedural data and in-hospital outcomes were collected. The primary outcome was in-hospital major adverse cardiovascular events (MACE), secondary (safety) outcomes were in-hospital definite stent thrombosis, Bleeding Academic Research Consortium bleeding, access-related complications (any) as well as peri-procedural complications. In total, 500 procedures were included in the study, 151 ACT and 349 fixed-dose. Patient demographics and medical history in both groups were well balanced, but those having ACTs were younger (63.2 ± 10.9 vs. 66.5 ± 11.3; P = 0.003) and less likely to have a history of coronary artery disease (74 vs. 82%; P = 0.032) or kidney failure. Procedural data were similar; however, total heparin dose and procedure length were higher in the ACT group (6232 ± 1388 vs.5032 ± 417 units; P < 0.001; 40.1 ± 14.0 vs. 30.3 ± 12.7 min; P < 0.001). Primary and secondary outcome events were rare and similar (MACE 1.1 vs. 1.3%; P = 0.86). A fixed-dose heparin injection (5000 IU) approach for elective PCI while omitting ACT offers slightly shortened procedural time and similar in-hospital safety profile.

Outcomes of uninterrupted vs interrupted Periprocedural direct oral Anticoagulants in atrial Fibrillation ablation: A meta-analysis.

BackgroundStudies indicate that uninterrupted anticoagulation (UA) is superior to interrupted anticoagulation (IA) in the periprocedural period during catheter ablation of atrial fibrillation. Still IA is followed in many centers considering the bleeding risk. This meta‐analysis compares interrupted and uninterrupted direct oral anticoagulation during catheter ablation of atrial fibrillation.MethodsA systematic search into PubMed, EMBASE, and the Cochrane databases was performed and five studies were selected that directly compared IA vs UA before ablation and reported procedural outcomes, embolic, and bleeding events. The primary outcome of the study was major adverse cerebro‐cardiovascular events.ResultsThe meta‐analysis included 840 patients with UA and 938 patients with IA. Median follow‐up was 30 days. Activated clotting time (ACT) before first heparin bolus was significantly longer with UA (P = .006), whereas mean ACT was similar between the two groups (P = .19). Total heparin dose needed was significantly higher with IA (mean, ‒1.61; 95% CI, ‒2.67 to ‒0.55; P = .003). Mean procedure time did not vary between groups (P = .81). Overall complication rates were low, with similar major adverse cerebro‐cardiovascular event (P = .40) and total bleeding (P = .55) rates between groups. Silent cerebral events (SCEs) were significantly more frequent with IA (log odds ratio, ‒0.90; 95% CI, ‒1.59 to ‒0.22; P < .01; I 2, 33%). Rates of major bleeding, minor bleeding, pericardial effusion, cardiac tamponade, and puncture complications were similar between groups.ConclusionsUA during atrial fibrillation ablation has similar bleeding event rates, procedural times, and mean ACTs as IA, with fewer SCEs.

Single centre evaluation of heparin administration by body mass index in elective cardiac surgery

IntroductionHeparin has an idiosyncratic anticoagulation response when administered to facilitate cardio-pulmonary bypass (CPB). (1)After an initial loading dose of 300 units per kilogramme (U/Kg) of heparin a number of our elective cardiac surgical patients need additional top-ups to maintain a target activated clotting time (ACT) of at least 420 seconds. This seems more evident in overweight and obese patients.We conducted a service evaluation study to investigate hour heparin administration practices and to understand how they are affected by patients’ BMI in elective cardiac surgery.MethodsWe undertook a cross-sectional observational studyWe analysed data on 150 elective cardiac surgical patients.Heparin doses were calculated in units per kilogramme (U/Kg) at 4 stages of surgery: FIRST – initial heparin bolus, PRE – additional top-ups before CPB, PRIME – heparin in the CPB circuit prime, ON- top-ups during CPB.Patients’ body mass index (BMI) was categorised as: LOW < 20, NORMAL 20 – 25, OVERWEIGHT 25.1 – 30, OBESE1 30.1 – 35, OBESE2/3 >35.1.Results are presented as medians with interquartile range (IQR), percentages and mean percentages with 95% confidence intervals (CI).ResultsMedian FIRST heparin doses (U/Kg) for BMI were:LOW 339 (IQR 58.6)NORMAL 343 (IQR 40.4)OVERWEIGHT 330 (IQR 35.7)OBESE1 308 (IQR 42.4)OBESE2/3 280 (IQR 39.6)The FIRST heparin dose was <300 U/Kg in 18% of patients.Depending on the FIRST heparin dose, top-ups required were:If <300 U/Kg: PRE 37%, ON 85% and both 33%If >300 U/Kg: PRE 8%, ON 42% and both 4%Overall, heparin top-ups were required PRE 13%, ON 49% and both 9% of the whole cohort.As heparin doses were given, the mean percentage contribution at each stage to the total heparin dose received was:FIRST 64.4, 95% CI [62.846, 65.934].PRE 2.4, 95% CI [1.3219, 3.4581].PRIME 25.2, 95% CI [24.1707, 26.1293].ON 8, 95% CI [6.5437, 9.5963].Depending on the FIRST heparin dose, the median (IQR) total heparin dose (U/Kg) was:If <300 U/Kg: 506 (IQR 44.7)If >300 U/Kg: 500 (IQR 74)DiscussionThis study has highlighted that in our clinical practice heavier patients received lower loading heparin doses.However, patients who were initially underdosed, went on to require additional heparin doses more frequently than not-underdosed patients.At the end of surgery, underdosed and not-underdosed patients received a similar median total dose of heparin.This study was not designed to identify the reasons our heavier patients tend to have lower heparin loading.This issue warrants further research. Heparin has an idiosyncratic anticoagulation response when administered to facilitate cardio-pulmonary bypass (CPB). (1) After an initial loading dose of 300 units per kilogramme (U/Kg) of heparin a number of our elective cardiac surgical patients need additional top-ups to maintain a target activated clotting time (ACT) of at least 420 seconds. This seems more evident in overweight and obese patients. We conducted a service evaluation study to investigate hour heparin administration practices and to understand how they are affected by patients’ BMI in elective cardiac surgery. We undertook a cross-sectional observational study We analysed data on 150 elective cardiac surgical patients. Heparin doses were calculated in units per kilogramme (U/Kg) at 4 stages of surgery: FIRST – initial heparin bolus, PRE – additional top-ups before CPB, PRIME – heparin in the CPB circuit prime, ON- top-ups during CPB. Patients’ body mass index (BMI) was categorised as: LOW < 20, NORMAL 20 – 25, OVERWEIGHT 25.1 – 30, OBESE1 30.1 – 35, OBESE2/3 >35.1. Results are presented as medians with interquartile range (IQR), percentages and mean percentages with 95% confidence intervals (CI). Median FIRST heparin doses (U/Kg) for BMI were: LOW 339 (IQR 58.6) NORMAL 343 (IQR 40.4) OVERWEIGHT 330 (IQR 35.7) OBESE1 308 (IQR 42.4) OBESE2/3 280 (IQR 39.6) The FIRST heparin dose was <300 U/Kg in 18% of patients. Depending on the FIRST heparin dose, top-ups required were: If <300 U/Kg: PRE 37%, ON 85% and both 33% If >300 U/Kg: PRE 8%, ON 42% and both 4% Overall, heparin top-ups were required PRE 13%, ON 49% and both 9% of the whole cohort. As heparin doses were given, the mean percentage contribution at each stage to the total heparin dose received was: FIRST 64.4, 95% CI [62.846, 65.934]. PRE 2.4, 95% CI [1.3219, 3.4581]. PRIME 25.2, 95% CI [24.1707, 26.1293]. ON 8, 95% CI [6.5437, 9.5963]. Depending on the FIRST heparin dose, the median (IQR) total heparin dose (U/Kg) was: If <300 U/Kg: 506 (IQR 44.7) If >300 U/Kg: 500 (IQR 74) This study has highlighted that in our clinical practice heavier patients received lower loading heparin doses. However, patients who were initially underdosed, went on to require additional heparin doses more frequently than not-underdosed patients. At the end of surgery, underdosed and not-underdosed patients received a similar median total dose of heparin. This study was not designed to identify the reasons our heavier patients tend to have lower heparin loading. This issue warrants further research.

Will high-dose heparin affect blood loss and inflammatory response in patients undergoing cardiopulmonary bypass?

We performed a randomized study to investigate if a high versus a standard dose of heparin dose during cardiopulmonary bypass could affect intra- and post-operative bleeding and reduce the inflammatory response. A total of 30 patients undergoing elective coronary artery bypass grafting were randomized into high or standard dose of heparin during cardiopulmonary bypass. Blood loss was documented peri- and post-operatively, and interleukin-6, tumor necrosis factor-α, and C3 were measured in conjunction with cardiopulmonary bypass. Data from 29 patients were analyzed after exclusion of one patient. The mean initial bolus and total heparin doses were 43,000 ± 5,800 IU versus 35,000 ± 4,100 IU, (p < 0.001), and 58,000 ± 9,500 IU versus 45,000 ± 7,900 IU, (p < 0.001) in the intervention and the control group, respectively. The median intra-operative bleeding was 150 mL (interquartile range 100-325) in the control versus 225 mL (IQR 200-350) in the intervention group, p = 0.15. The median chest tube blood loss 12 hour post-operatively was 300 mL (interquartile range 250-385) in the control versus 450 mL (IQR 315-505) in the intervention group, p = 0.029. There was no significant difference between the control group and the intervention group during cardiopulmonary bypass for the measured inflammatory markers interleukin-6 (p = 0.98), tumor necrosis factor-α (p = 0.72), or C3 (p = 0.13). This small study showed a small increase of post-operative bleeding associated with higher heparin dosage in conjunction with cardiopulmonary bypass but did not demonstrate an effect of heparin on the inflammatory response to cardiopulmonary bypass.

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route.

AimCoronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction.MethodsAll patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale.ResultsA total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 (n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 (n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 (p = 0.01).ConclusionA protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

Comparison between two protocols for deflation of the TR band following coronary procedures via the radial route

AimCoronary interventions are increasingly being performed via the radial rather than femoral route because of the lower complication rate. Compression devices such as the TR band are used to achieve hemostasis after the procedure. At present, there are no clear protocols for the deflation of the band. In this study we compared two protocols (early deflation with increased intervals vs. late deflation with smaller intervals) in terms of total time to band removal and complications, and patient and staff satisfaction. MethodsAll patients who underwent a transradial coronary procedure and had a TR band fitted were enrolled into the study. The TR band was applied using the patent hemostasis method (2 ml air pushed in after the radial pulse appears on pulse oximetry after full occlusion with 16 ml air). Patients were randomly assigned to either protocol. Protocol 1 involved removal of 2 ml of air starting 1 hour after the sheath removal and then removal of 2 ml every 30 minutes until the band came off. Protocol 2 involved removal of 4 ml of air 2 hours after the sheath removal and then further 4 ml of air every 15 minutes until the band came off. Patient and staff satisfaction was measured with a visual analogue scale. ResultsA total of 174 patients were recruited (mean age, 60 ± 11 years; 127 male, 47 female). The baseline characteristics including total heparin dose and type of procedure, in the two arms were the same. Protocol 2 (n = 84) was associated with a significantly lower time to TR band removal as compared to protocol 1 (n = 90; 201 ± 43 min vs. 274 ± 54 min; p < 0.001). There was no difference in complications such as bleeding or hematoma formation between the two groups. Patient satisfaction was the same between the two groups. However, the staff preferred protocol 1 (p = 0.01). ConclusionA protocol of delayed initiation of TR band deflation followed by quick deflations is associated with a lower time to band removal with no increase in bleeding complications or patient satisfaction. However, the staff preferred longer intervals between deflations.

The use of activated partial thromboplastin time versus antifactor Xa assay in monitoring continuous unfractionated heparin infusion therapy in obstetric intensive care unit

BackgroundUnfractionated heparin (UFH) infusion therapy needs accurate tight control to prevent overanticoagulation that may result in hemorrhagic complications and also to prevent sub therapeutic level that may result in thrombotic complications. The aim of this study was to compare the most popular monitoring tool activated aPTT versus antifactor Xa to reach accurate monitor to UFH therapy in critically ill pregnant females.ResultsTime to reach therapeutic level as well as total heparin dose required to reach this therapeutic level were much lower in the anti-Xa group when compared to aPTT group.ConclusionThe use of anti-Xa-based protocol to monitor UFH infusion therapy resulted in better therapeutic control as it resulted in earlier achievement of therapeutic level and lower heparin dose requitments.

Radial versus femoral approach for saphenous vein grafts angiography and interventions

Coronary angiography and intervention to saphenous venous grafts (SVGs) remain challenging. This study aimed to investigate the feasibility and safety of the radial approach compared to femoral access in a large cohort of patients undergoing SVG angiography and intervention. Data from 1,481 patients from Canada, United States, and Spain who underwent procedures between 2010 and 2016 were collected. Patients must have undergone SVG coronary angiography and/or intervention. Demographics, procedural data, and in-hospital complications were recorded. Procedures were undertaken by either the radial (n = 863, 211 intervention) or femoral (n = 618, 260 intervention) approach. The mean number of SVGs per patient was similar between groups (radial 2.3 ± 0.7 vs femoral 2.6 ± 1.1, P = .61), but the radial group required a fewer number of catheters (2.6 ± 1.7 vs 4.1 ± 1.1, P < .001). Fluoroscopy time was comparable between groups, and there was a trend toward lower contrast volume in the radial group (P = .045). Overall, the total dose of heparin was significantly higher in the radial group (P < .001); however, radial patients experienced significantly less access-site bleeding complications (P < .001). Outpatients undergoing radial SVG interventions had a higher likelihood of a same-day discharge home (P < .001). Radial access for SVG angiography and intervention is safe and feasible, without increasing fluoroscopy time. In experienced centers, radial access was associated with fewer catheters used, lower contrast volume, and lower rate of vascular access-site bleeding complications. Moreover, outpatients undergoing SVG percutaneous coronary intervention though the radial approach had a higher likelihood of a same-day discharge home.

Heparin dose calculated according to lean body weight during on-pump heart surgery.

The aim of this study is to compare heparin dose regimen calculated based on the lean body weight with traditional heparin regimen in terms of ensuring adequate anticoagulation and complications associated with perioperative bleeding. This prospective, single-blind, randomized study included a total of 100 adult patients (42 males, 58 females; mean age 52.7 years; range, 22 to 84 years) undergoing elective valve surgery with cardiopulmonary bypass between June 2016 and January 2017. Prior to cardiopulmonary bypass, heparin dose was adjusted as 4 mg/kg, according to the actual body weight (n=50) and lean body weight (n=50). The minimal activated clotting time target value was accepted as 480 sec for cardiopulmonary bypass initiation. Demographic and hemodynamic data, post-heparin activated clotting time, additional heparin and perioperative transfusion, postoperative drainage volumes, reoperations, and mortality were recorded. Demographic data, cross-clamp and cardiopulmonary bypass times, and intraoperative transfusion requirement were not significantly different between the groups. The initial and total doses of heparin, as well as the total dose of protamine, were significantly higher in the actual body weight group. Postoperative transfusion rates were also higher in this group. None of the patients in the lean body weight group required reoperation, while three patients in the actual body weight group underwent reoperation. Our study results showed that adequate anticoagulation was achieved with the titration of heparin dose calculated according to the lean body weight during cardiopulmonary bypass and reduced total heparin and protamine doses decreased postoperative bleeding and blood product transfusion requirement.

Calculation Algorithm Reduces Protamine Doses Without Increasing Blood Loss or the Transfusion Rate in Cardiac Surgery: Results of a Randomized Controlled Trial

The aim of the study was to investigate whether the HeProCalc algorithm affects heparin and protamine dosage, postoperative blood loss, and transfusion rate. Randomized controlled trial. University hospital. The study comprised 210 cardiac surgery patients undergoing cardiac surgery with cardiopulmonary bypass. Twenty patients were excluded because of re-exploration for localized surgical bleeding (n = 9), violation of protocol (n = 2), aprotinin use (n = 3 and nadir body temperature <32°C (n = 6). Study participants were randomly assigned to either traditional heparin and protamine dosage based on body weight only (control group) or dosage based on the HeProCalc algorithm (intervention group). The initial median heparin dose was 32,500 IU (interquartile range [IQR] 30,000-35,000) in the intervention group compared with 35,000 IU (IQR 30,000-37,500) (p = 0.025) in the control group. The total heparin dose in the intervention group was 40,000 IU (IQR 32,500-47,500) compared with 42,500 IU (IQR 35,000-50,000) in the control group (p = 0.685). The total protamine dose was 210 mg (IQR 190-240) in the intervention group compared with 350 mg (IQR 300-380) (p < 0.001) in the control group. The ratio of total protamine to initial dose of heparin in the intervention group was 0.62 compared with 1.0 (p < 0.001). The amount of chest tube bleeding after 12 postoperative hours was 320 mL (IQR 250-460) in the intervention group compared with 350 mL (IQR 250-450) (p = 0.754) in the control group. Neither the transfusion rate nor postoperative blood loss differed significantly between the 2 groups. Use of the HeProCalc algorithm reduced protamine dosage and the protamine/heparin ratio after cardiopulmonary bypass compared with conventional dosage based on weight without significant effect on postoperative blood loss or the transfusion rate.

Adjusted calculation model of heparin management during cardiopulmonary bypass in obese patients: A randomised controlled trial.

Anticoagulation during cardiopulmonary bypass (CPB) is usually adapted to total body weight (TBW). This may be inaccurate in obese patients and lead to heparin overdose with a risk of bleeding. To validate the efficacy and safety of an adjusted calculation model of heparin dosing based on ideal body weight (IBW) rather than TBW in obese CPB patients, with an expected target mean plasma heparin concentration of 4.5 IU ml after onset of CPB in the experimental group. Randomised controlled study. University hospital. Sixty obese patients (BMI ≥ 30 kg m) scheduled for CPB were included from January to June 2016. Patients received a bolus dose of unfractionated heparin of either 300 IU kg of TBW or 340 IU kg of IBW before onset of CPB. Additional adjusted boluses were injected to maintain an activated clotting time (ACT) of at least 400 s. Plasma heparin concentration and ACT were measured at different time points. Total heparin doses and transfusion requirements were recorded. The target heparin concentration of 4.5 IU ml was reached in the IBW group at the onset of CPB and maintained at all time points during CPB. Heparin concentrations were significantly higher in the TBW group after the bolus (6.52 ± 0.97 vs. 4.54 ± 1.13 IU ml, P < 0.001) and after cardioplegia (5.10 ± 1.03 vs. 4.31 ± 1.00 IU ml, P = 0.02). Total heparin doses were significantly higher in the TBW group. Mean ACT was significantly lower in the IBW group but remained over 400 s during CPB. The correlation between heparin and ACT was poor. Peri-operative bleeding and transfusion requirements were comparable. No thrombotic event occurred in the CPB circuit. The current IBW-adjusted regimen of heparin administration may be used efficiently in obese CPB patients, thereby avoiding overdose which cannot be accurately assessed by ACT monitoring alone. ClinicalTrials.gov identifier: NCT02675647.

Radial versus femoral approach for same-day inter-facility transfer for percutaneous coronary intervention.

The use of radial approach for coronary angiography, followed by same-day inter-facility transfer for percutaneous coronary intervention (PCI) has not yet been evaluated. We sought to assess the safety and feasibility of using the transradial as compared to the transfemoral approach in patients undergoing diagnostic angiogram with same-day transfer to a PCI facility. Patients that underwent diagnostic coronary angiography between January 2011 and June 2017 in a referring facility, and were transferred for same-day PCI were included. Patients' demographics, as well as procedural data and in-hospital outcome, were collected. Three hundred fifty-two participants were included. Of these, 36 (10.2%) patients received transradial access. Patients in the transradial group were older (68 ± 10 vs 62 ± 12 years, P = 0.007), and received a significantly higher total dose of heparin including both, diagnostic and PCI procedures (5935 ± 1865 vs 10029 ± 2771 units, P < 0.001). None of the transradial patients experienced bleeding or access-related complications. In the transfemoral group, 9 (3%) vascular-access complications were recorded. Contrast volume was lower for transradial patients (177 ± 47 vs 216 ± 75 mL, P < 0.001). A higher proportion of outpatients were discharged from the PCI-center the same day after transradial procedures (53% vs 1.3%, P < 0.001). Transradial access for inter-facility transfer for PCI after diagnostic angiogram appears safe and feasible, without increasing the risk for ischemic hand complications. Transradial access was associated with fewer bleeding and vascular access-site complications, and with a higher likelihood for a same-day discharge home in outpatients.

The activated clotting time in cardiac surgery: should Celite or kaolin be used?

Both kaolin- and Celite-activated clotting times (ACT) are used to guide anticoagulation during cardiopulmonary bypass. It is unknown whether these methods lead to similar management procedures for anticoagulation in patients and are thus interchangeable in terms of bias, precision and variability. We randomized 97 patients undergoing coronary artery bypass grafting or aortic valve replacement to either kaolin- or Celite-guided anticoagulation. The ACT was measured simultaneously with the other method. We administered 300 IU/kg heparin to obtain initial ACT values greater than 400 s and additional heparin in each group using the minimum value of duplicate measurements according to a predefined protocol. The primary end point was the total heparin dose and the number of heparin supplements. The total heparin dose per patient in the 48 Celite-guided patients was 35 271 ± 12 406 IU with 51 supplements and in the 49 kaolin-guided patients, 35 997 ± 11 540 IU ( P = 0.77) with 56 supplements ( P = 0.53). Postoperative thrombin generation time, fibrinolytic response time, chest tube loss and transfusion requirements were not different between the two groups. However, the methods differed in individual patients with regard to supplemental heparin ( P = 0.002). Bias between methods at baseline was +10.3%, Celite being higher, and changed to a value of -12.9% at 2 h bypass. The coefficient of variation at baseline for individual patients was 2.6 times larger with kaolin than with Celite ( P < 0.001). Correlation between ACT values at baseline was only 45%. Kaolin- and Celite-guided management of anticoagulation is clinically not different, but the methods are not interchangeable. www.trialregister.nl identifier 1738.