Anticoagulation Management Strategies Research Articles

Association of Direct Oral Anticoagulation Management Strategies With Clinical Outcomes for Adults With Atrial Fibrillation

Anticoagulation management services (AMSs; ie, warfarin clinics) have evolved to include patients treated with direct oral anticoagulants (DOACs), but it is unknown whether DOAC therapy management services improve outcomes for patients with atrial fibrillation (AF). To compare outcomes associated with 3 DOAC care models for preventing adverse anticoagulation-related outcomes among patients with AF. This retrospective cohort study included 44 746 adult patients with a diagnosis of AF who initiated oral anticoagulation (DOAC or warfarin) between August 1, 2016, and December 31, 2019, in 3 Kaiser Permanente (KP) regions. Statistical analysis was conducted from August 2021 through May 2023. Each KP region used an AMS to manage warfarin but used distinct approaches to DOAC care: (1) usual care (UC) by the prescribing clinician, (2) UC plus an automated population management tool (PMT), or (3) pharmacist-managed AMS care. Propensity scores and inverse probability of treatment weights (IPTWs) were estimated. Direct oral anticoagulant care models were first indirectly compared using warfarin as a common comparator within each region and then directly compared across regions. Patients were followed up until the first occurrence of an outcome (composite of thromboembolic stroke, intracranial hemorrhage, other major bleeding, or death), discontinuation of KP membership, or December 31, 2020. Overall, 44 746 patients were included: 6182 in the UC care model (3297 DOAC; 2885 warfarin), 33 625 in the UC plus PMT care model (21 891 DOAC; 11 734 warfarin), and 4939 in the AMS care model (2089 DOAC; 2850 warfarin). Baseline characteristics (mean [SD] age, 73.1 [10.6] years, 56.1% male, 67.2% non-Hispanic White, median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65-74 years, female sex] score of 3 [IQR, 2-5]) were well balanced after IPTW. Over a median follow-up of 2 years, patients who received the UC plus PMT or AMS care model did not have significantly better outcomes than those who received UC. The incidence rate of the composite outcome was 5.4% per year for DOAC and 9.1% per year for warfarin for those in the UC group, 6.1% per year for DOAC and 10.5% per year for those in the UC plus PMT group, and 5.1% per year for DOAC and 8.0% per year for those in the AMS group. The IPTW-adjusted hazard ratios (HRs) for the composite outcome comparing DOAC vs warfarin were 0.91 (95% CI, 0.79-1.05) in the UC group, 0.85 (95% CI, 0.79-0.90) in the UC plus PMT group, and 0.84 (95% CI, 0.72-0.99) in the AMS group (P = .62 for heterogeneity across care models). When directly comparing patients receiving DOAC, the IPTW-adjusted HR was 1.06 (95% CI, 0.85-1.34) for the UC plus PMT group vs the UC group and 0.85 (95% CI, 0.71-1.02) for the AMS group vs the UC group. This cohort study did not find appreciably better outcomes for patients receiving DOAC who were managed by either a UC plus PMT or AMS care model compared with UC.

Anticoagulation management and related outcomes in patients with cancer-associated thrombosis and thrombocytopenia: A systematic review and meta-analysis

BackgroundPatients with cancer have an increased risk of both venous thromboembolism (VTE) requiring anticoagulation and thrombocytopenia. The optimal management is unclear. We performed a systematic review and meta-analysis to evaluate the outcomes in these patients. MethodsWe searched MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials from inception to February 5, 2022. Studies assessing adult patients with cancer-associated thrombosis and platelet count <100 × 109/L were included. Three anticoagulation management strategies were reported: full dose, modified dose, or no anticoagulation. The primary efficacy outcome was recurrent VTE, and the primary safety outcome was major bleeding. The incidence rates of thrombotic and bleeding outcomes by anticoagulation management strategies were descriptive, and were pooled using random effects model and expressed as events per 100 patient-months with associated 95 % confidence intervals (CI). ResultsWe included 19 observational cohort studies (N = 1728 patients) in the systematic review, with 10 included in the meta-analysis (N = 707 patients). Approximately 90 % of patients had hematological malignancies, with low-molecular-weight heparin being the main anticoagulant. The rates of recurrent VTE and bleeding complications were high regardless of management strategies – recurrent VTE on full dose: 2.65/100 patient-months (95 % CI 1.62–4.32), modified dose: 3.51/100 patient-months (95 % CI 1.00–12.39); major bleeding on full dose: 4.45/100 patient-months (95 % CI 2.80–7.06), modified dose: 4.16/100 patient-months (95 % CI 2.24–7.74). There was serious risk of bias in all studies. ConclusionsPatients with cancer-associated thrombosis and thrombocytopenia have high risks of both recurrent VTE and major bleeding, but current literature is significantly limited to guide the best management.

Shared Experiences

Shared Experiences

Practice guidelines of thromboprophylaxis and management of anticoagulation in hospitalized patients with COVID-19

Corona virus disease 2019 (COVID-19) can lead to thrombotic complications through multiple mechanisms. Venous thromboembolism (VTE) is one of the most important causes of death or poor prognosis in hospitalized patients with COVID-19. The prognosis of thrombosis in COVID-19 patients can be improved with VTE and bleeding risk assessment, as well as appropriate VTE prophylaxis. However, in current clinical practice, there still is much room for progress in choose of appropriate prevention methods, anticoagulant regimens, doses, and courses based on the severity and specific condition of COVID-19 patients and dynamically balancing the risk of thrombosis and bleeding. In the past three years, a series of authoritative guidelines related to VTE and COVID-19 and high-quality, evidence-based medical research evidence have been released both in domestic and internationally. Based on this, in order to better guide the clinical practice in China, multi-discipline expert discussions and Delphi expert demonstrations formulated the"Thromboprophylaxis and management of anticoagulation in hospitalized patients with COVID-19: an update of the CTS guidelines", aiming to address the issues of thrombosis risk and prevention strategies caused by COVID-19, anticoagulant management of hospitalized patients, diagnosis and treatment of thrombosis, anticoagulant management of special populations, interaction and adjustment strategies of antiviral and anti-inflammatory drugs and anticoagulant drugs, follow-up after discharge and many other aspects of clinical situations. Recommendations and clinical guidelines are provided for appropriate thromboprophylaxis and anticoagulation management strategies for VTE in patients with COVID-19.

Optimizing pharmacotherapy regimens in adult patients receiving extracorporeal membrane oxygenation: A narrative review for clinical pharmacists

AbstractExtracorporeal membrane oxygenation (ECMO) is a complex therapy aimed at providing mechanical support for patients with severe, life‐threating cardiac and/or respiratory failure. Research has demonstrated variability in pharmacokinetic changes in the critically ill patient population receiving ECMO. There is a need to understand the complexity of these pharmacokinetic changes to provide optimal pharmacotherapeutic regimens thereby maximizing effectiveness and mitigating harm. However, the number of pharmacokinetic studies in patients receiving ECMO remains small, and very few prospective studies have been published addressing optimal analgesic, sedative, or antimicrobial therapy. Anticoagulation is an additional important component of ECMO therapy but the preferred agent as well as dosing and monitoring strategy are unclear. The purpose of this narrative review is to discuss analgesia and sedation, antimicrobial, and anticoagulation management strategies in adult patients receiving ECMO.

Practice guidelines of thromboprophylaxis and management of anticoagulation in hospitalized patients with COVID-19

Corona virus disease 2019 (COVID-19) can lead to thrombotic complications through multiple mechanisms. Venous thromboembolism (VTE) is one of the most important causes of death or poor prognosis in hospitalized patients with COVID-19. The prognosis of thrombosis in COVID-19 patients can be improved with VTE and bleeding risk assessment, as well as appropriate VTE prophylaxis. However, in current clinical practice, there still is much room for progress in choose of appropriate prevention methods, anticoagulant regimens, doses, and courses based on the severity and specific condition of COVID-19 patients and dynamically balancing the risk of thrombosis and bleeding. In the past three years, a series of authoritative guidelines related to VTE and COVID-19 and high-quality, evidence-based medical research evidence have been released both in domestic and internationally. Based on this, in order to better guide the clinical practice in China, multi-discipline expert discussions and Delphi expert demonstrations formulated the"Thromboprophylaxis and management of anticoagulation in hospitalized patients with COVID-19: an update of the CTS guidelines", aiming to address the issues of thrombosis risk and prevention strategies caused by COVID-19, anticoagulant management of hospitalized patients, diagnosis and treatment of thrombosis, anticoagulant management of special populations, interaction and adjustment strategies of antiviral and anti-inflammatory drugs and anticoagulant drugs, follow-up after discharge and many other aspects of clinical situations. Recommendations and clinical guidelines are provided for appropriate thromboprophylaxis and anticoagulation management strategies for VTE in patients with COVID-19.

Management of Anticoagulation and Related Outcomes in Patients with Cancer-Associated Thrombosis and Thrombocytopenia: A Systematic Review and Meta-Analysis

Background: Patients with cancer have an increased risk of venous thromboembolism (VTE) requiring anticoagulation, as well as an increased risk of thrombocytopenia due to cancer therapies or cancer itself. The optimal management of patients with VTE and thrombocytopenia is unclear. Objective: We performed a systematic review and meta-analysis to evaluate the rates of recurrent VTE and major bleeding in patients with cancer associated thrombosis and thrombocytopenia according to different anticoagulation management strategies. Methods: We searched MEDLINE, Embase, Scopus, and Cochrane Central Register of Controlled Trials from inception to February 5, 2022. Studies assessing adult patients with cancer associated thrombosis and thrombocytopenia (platelet count < 100 x 109/L) due to malignancy or cancer therapy were included. Three main anticoagulation management strategies were reported: full dose (therapeutic dose anticoagulation +/- platelet transfusion support), modified dose (including 50% dose, prophylactic dose, or shortened duration of anticoagulation), or no anticoagulant. The primary efficacy outcome was recurrent VTE, and the primary safety outcome was major bleeding as defined by individual studies. Secondary outcomes included clinically relevant non-major bleeding, total bleeding events, and all-cause mortality. By using R software (version 4.0.3), the incidence rates of thrombotic and bleeding outcomes by anticoagulation management strategies were pooled using random effects model and expressed as events per 100 patient-months with associated 95% confidence intervals (CI). The quality of studies was assessed by ROBINS-I tool. Results: After screening 4,341 records, we included 19 studies (N=1,728 patients with platelet count < 100 x 109/L) in the systematic review, 12 of which were included in the meta-analysis (N=790) (Figure 1). There were no RCTs, two prospective cohort studies, and the rest were retrospective cohort studies. Most studies were small (N=13-471) and limited to patients with platelet count < 50 x 109/L. The majority (~90%) of patients had hematological malignancies or stem cell transplant. Low-molecular-weight heparin was the main anticoagulant reported. All studies were judged to have serious risk of bias, mainly from bias due to confounding and bias due to deviations from intended interventions. The rates of recurrent VTE, major bleeding, and total bleeding events stratified by anticoagulation management strategies (full dose, modified dose, no anticoagulation) were summarized in Table 1. The rates of recurrent VTE and bleeding complications were high regardless of the management strategies - recurrent VTE on full dose anticoagulant: 2.97 per 100 patient-months (95% confidence interval [CI] 1.86-4.75), modified dose: 7.32 per 100 patient-months (95% CI 3.59-14.94); major bleeding on full dose: 4.36 per 100 patient-months (95% CI 2.53-7.50), modified dose: 4.34 per 100 patient-months (2.30-8.20) (Table 1). There was high degree of heterogeneity in the patient population included, acuity and type of VTE, bleeding criteria used, and follow-up durations. Most studies did not account for the differences in baseline characteristics when outcomes associated with different anticoagulation strategies were reported and analyzed, which could influence the results. Conclusions: Patients with cancer associated thrombosis and thrombocytopenia have high risks of both recurrent VTE and major bleeding. Our systematic review and meta-analysis demonstrated significant heterogeneity in study conduct and reporting. Our ability to draw a firm conclusion to guide management from the current literature is severely hindered by this limitation. RCTs are needed to define the optimal care for this high-risk population. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Calf Vein Thrombosis Outcomes Comparing Anticoagulation and Serial Ultrasound Imaging Management Strategies

ObjectiveTo compare outcomes among patients with calf deep vein thrombosis (DVT) stratified by management strategy because distal or calf DVT is said to have low rates of propagation, embolization, and recurrence and, as such, guideline recommendations include provisions for serial imaging without treatment. Patients and MethodsConsecutive patients with ultrasound-confirmed acute DVT involving the calf veins (January 1, 2016, to August 1, 2018) were identified by scrutinizing the Gonda Vascular Center Ultrasound database. Patients were segregated into 2 categories depending on management strategy; anticoagulation vs serial surveillance ultrasound without anticoagulation. Outcomes including venous thromboembolism (VTE) recurrence, bleeding, death, and net clinical benefit were compared by treatment strategy. ResultsThere were 483 patients with calf DVT identified; 399 were treated with anticoagulation therapy and 84 were managed with surveillance ultrasound. Patients in the surveillance group were older (70.0±13.9 vs 63.0±14.9 years; P<.001) and more likely to have had a recent hospitalization (76.2% [64/84] vs 45.4% [181/399]; P<.001). Common reasons for choosing ultrasound surveillance included guideline prescriptive (58.3% [49/84]), active bleeding (21.4% [18/84]), and recent surgery (17.9% [15/84]). The VTE recurrence composite was lower for patients treated with anticoagulants (7.3% [29/399]) compared with surveillance (14.3% [12/84]; P=.04). The DVT propagation was less frequent in the treated group (2.8% [11/399] vs 8.3% [7/84]; P=.01). There was no difference in bleeding or mortality outcomes by management strategy. Net clinical benefit (VTE recurrence plus major bleeding) favored anticoagulant therapy (9.8% [39/399] vs 20.2% [17/84]; P<.01). ConclusionPatients with calf DVT treated with anticoagulants had significantly better outcomes compared with those managed by a strategy of serial ultrasound surveillance without increasing bleeding outcomes.

Anticoagulation in patients with atrial fibrillation, thrombocytopenia and hematological malignancy

Managing anticoagulation in hematological malignancy patients with atrial fibrillation and thrombocytopenia is a clinical challenge with limited data. We aimed to identify anticoagulation management strategies and evaluate bleeding and thrombosis rates associated with each approach. A retrospective cohort study in Israel and the Netherlands was conducted. Patients with hematological malignancy and atrial fibrillation were indexed when platelets were < 50 × 109/L and followed for 30days. The cohort included 61 patients of whom 42 (69%) had anticoagulation held at index. On multivariate analysis, holding anticoagulation was associated with age < 65years and atrial fibrillation diagnosed within 30days prior index. Clinically relevant bleeding was diagnosed in 7 (16.7%) and 1 (5.3%) of patients who had anticoagulation held and continued respectively, while arterial thromboembolism occurred in 1 patient in each group (2.4% and 5.3%, respectively). All-cause mortality rate was high at 45%. Accordingly, the 30-day bleeding risk may outweigh the risk of arterial thromboembolism in hematological malignancy, platelets < 50 × 109/L and atrial fibrillation.

Impact of different anticoagulation management strategies on outcomes in atrial fibrillation: Dutch and Belgian results from the GARFIELD‐AF registry

BackgroundThe uptake rate of non–vitamin K oral anticoagulants (NOAC) for the treatment of non‐valvular atrial fibrillation (AF) was far lower in the Netherlands (NL) compared to Belgium (BE). Also, patients on VKA in NL were treated with a higher target international normalized ratio (INR) range of 2.5 to 3.5. ObjectivesTo explore the effect of these differences on thromboembolism (TE) and bleeding. MethodsData from the GARFIELD‐AF registry was used. Patients with new‐onset AF and ≥1 investigator‐determined risk factor for stroke were included between 2010 and 2016. Event rates from 2 years of follow‐up were used. ResultsIn NL and BE, 1186 and 1705 patients were included, respectively. Female sex (42.3% vs 42.2%), mean age (70.7 vs 71.3 years), CHA2DS2‐VASc (3.1 vs 3.1), and HAS‐BLED score (1.4 vs 1.5) were comparable between NL and BE. At diagnosis in NL vs BE, 72.1% vs 14.6% received vitamin K antagonists (VKA) and 17.8% vs 65.5% NOACs, varying greatly across cohorts. Mean INR was 2.9 (±1.0) and 2.4 (±1.0) in NL and BE, respectively. Event rates per 100 patient‐years in NL and BE, respectively, of all‐cause mortality (3.38 vs 3.90; hazard ratio [HR] 0.86, 95% confidence interval [CI] 0.65‐1.15), ischemic stroke/TE (0.82 vs 0.72; HR 1.14, 95% CI 0.62‐2.11), and major bleeding (2.06 vs 1.54; HR 1.33, 95% CI 0.89‐1.99) did not differ significantly. ConclusionsIn GARFIELD‐AF, despite similar characteristics, patients on anticoagulants were treated differently in NL and BE. Although the rate of major bleeding was 33% higher in NL, variations in bleeding, mortality, and TE rates were not statistically significant.

Comparison of anticoagulation strategies for veno-venous ECMO support in acute respiratory failure

BackgroundExtracorporeal membrane oxygenation (ECMO) support in acute respiratory failure may be lifesaving, but bleeding and thromboembolic complications are common. The optimal anticoagulation strategy balancing these factors remains to be determined. This retrospective study compared two institutional anticoagulation management strategies focussing on oxygenator changes and both bleeding and thromboembolic events.MethodsWe conducted a retrospective observational cohort study between 04/2015 and 02/2020 in two ECMO referral centres in Germany in patients receiving veno-venous (VV)-ECMO support for acute respiratory failure for > 24 h. One centre routinely applied low-dose heparinization aiming for a partial thromboplastin time (PTT) of 35–40 s and the other routinely used a high-dose therapeutic heparinization strategy aiming for an activated clotting time (ACT) of 140–180 s. We assessed number of and time to ECMO oxygenator changes, 15-day freedom from oxygenator change, major bleeding events, thromboembolic events, 30-day ICU mortality, activated clotting time and partial thromboplastin time and administration of blood products. Primary outcome was the occurrence of oxygenator changes depending on heparinization strategy; main secondary outcomes were the occurrence of severe bleeding events and occurrence of thromboembolic events. The transfusion strategy was more liberal in the low-dose centre.ResultsOf 375 screened patients receiving VV-ECMO support, 218 were included in the analysis (117 high-dose group; 101 low-dose group). Disease severity measured by SAPS II score was 46 (IQR 36–57) versus 47 (IQR 37–55) and ECMO runtime was 8 (IQR 5–12) versus 11 (IQR 7–17) days (P = 0.003). There were 14 oxygenator changes in the high-dose group versus 48 in the low-dose group. Freedom from oxygenator change at 15 days was 73% versus 55% (adjusted HR 3.34 [95% confidence interval 1.2–9.4]; P = 0.023). Severe bleeding events occurred in 23 (19.7%) versus 14 (13.9%) patients (P = 0.256) and thromboembolic events occurred in 8 (6.8%) versus 19 (19%) patients (P = 0.007). Mortality at 30 days was 33.3% versus 30.7% (P = 0.11).ConclusionsIn this retrospective study, ECMO management with high-dose heparinization was associated with lower rates of oxygenator changes and thromboembolic events when compared to a low-dose heparinization strategy. Prospective, randomized trials are needed to determine the optimal anticoagulation strategy in patients receiving ECMO support.

Anticoagulation Management in Severe Coronavirus Disease 2019 Patients on Extracorporeal Membrane Oxygenation

ObjectiveTo explore special coagulation characteristics and anticoagulation management in extracorporeal membrane oxygenation (ECMO)–assisted patients with coronavirus disease 2019 (COVID-19).DesignSingle-center, retrospective observation of a series of patients.ParticipantsLaboratory-confirmed severe COVID-19 patients who received venovenous ECMO support from January 20–May 20, 2020.InterventionsThis study analyzed the anticoagulation management and monitoring strategies, bleeding complications, and thrombotic events during ECMO support.Measurements and Main ResultsEight of 667 confirmed COVID-19 patients received venovenous ECMO and had an elevated D-dimer level before and during ECMO support. An ECMO circuit pack (oxygenator and tubing) was replaced a total of 13 times in all 8 patients, and coagulation-related complications included oxygenator thrombosis (7/8), tracheal hemorrhage (5/8), oronasal hemorrhage (3/8), thoracic hemorrhage (3/8), bleeding at puncture sites (4/8), and cannulation site hemorrhage (2/8).ConclusionsHypercoagulability and secondary hyperfibrinolysis during ECMO support in COVID-19 patients are common and possibly increase the propensity for thrombotic events and failure of the oxygenator. Currently, there is not enough evidence to support a more aggressive anticoagulation strategy.

Mo1754 POST-POLYPECTOMY BLEEDING IN PATIENTS ON DIRECT-ACTING ORAL ANTICOAGULANTS: A SYSTEMATIC REVIEW AND META-ANALYSIS

Since coming into practice in 2010, direct oral anticoagulants (DOACs) have become an increasingly popular form of anticoagulation. However, it is unclear which form of polypectomy intervention or peri-procedural anticoagulation management is best for reducing post-polypectomy bleeding (PPB) risk in the setting of DOAC usage. The aim of our study was to assess the efficacy of polypectomy approaches and management of anticoagulation in minimizing PPB in patients on DOACs. A systematic review of electronic databases was performed through September 2019, including PubMed, MEDLINE, EMBASE, and Cochrane. Two authors independently screened manuscripts and extracted data using Covidence. We included prospective, retrospective, case-control, cohort, and randomized controlled trials that evaluated PPB in patients on DOACs who underwent colonoscopy with polypectomy. The primary outcome was overall PPB rate in patients undergoing snare polypectomy versus endoscopic mucosal resection. We compared approaches to anticoagulation which included heparin bridge, no heparin bridge, and continuation of DOAC. Random effect analyses and 95% confidence intervals (CI) were calculated for all outcomes. Between-study heterogeneity was quantified using the Q statistic and I2 (p<0.05 was considered significant). 973 citations were reviewed, of which 9 were included in the final analysis. The majority were retrospective cohort studies. In total, the studies comprised 2,977 patients with average age of 72.4 years and study follow-up period ranging from 2 to 6 years. Studies defined PPB as hematochezia requiring endoscopic hemostasis occurring 14 to 30 days post endoscopy. Endoscopic submucosal dissection was associated with a significantly higher rate of PPB compared to snare polypectomy. There was a tendency towards higher PPB rates in hot snare versus cold snare polypectomy cases, though this did not reach statistical significance. There were no statistically significant bleeding rates amongst various anticoagulation management strategies. However, PPB effects sizes did tend to be larger in cases where anticoagulation was continued peri-procedurally (Table 1). There was insufficient data to determine the role of prophylactic clips after polypectomy. PPB is a serious adverse effect of colonoscopy. We found that in patients on DOACs, performing endoscopic submucosal dissection is associated with higher PPB rates compared to snare polypectomy. However, for patients at high risk of thromboembolism, our results suggest that continuation of DOAC may not increase the risk of PPB as compared to heparin bridging or discontinuation of anticoagulation altogether. More high-quality studies are needed to further discern amongst various anticoagulation and PPB-prevention strategies.

Periprocedural Outcomes in Patients on Chronic Anticoagulation Undergoing Fistulograms

Management of antithrombotic therapy with warfarin in patients undergoing fistulograms and possible interventions is controversial and difficult because of lack of adequate outpatient bridging options. Our goal was to assess periprocedural outcomes in patients managed using different anticoagulation strategies. A retrospective, single-institution analysis of all patients on chronic anticoagulation with warfarin undergoing fistulograms from 2011 to 2017 was performed. Anticoagulation management strategies were classified as suspended warfarin (SW), continued warfarin (CW), and a heparin bridge with suspended warfarin (HB). Periprocedural outcomes were analyzed. There were 87 patients on chronic anticoagulation with warfarin who underwent 175 fistulograms. Median age was 63years, and 43.4% were women. Indications for warfarin included atrial fibrillation (53%), prior pulmonary embolism/deep vein thrombosis (29%), and hypercoagulable state (14%). Distribution was SW (60%), CW (26%), and HB (14%). Approximately half (53%) were same-day procedures, 30% occurred during access-related admissions, and 14% were performed during nonaccess-related admissions. Common indications for a fistulogram included difficulty with dialysis (63.4%), access thrombosis (20.6%), and poor maturation (10.3%). Interventions included angioplasty (82.9%), thrombectomy/embolectomy (20.6%), and stenting (8.6%). Thirty-day outcomes for SW versus CW versus HB were similar for bleeding complications (5.7%, 6.5%, 8.3%; P=0.89), systemic thrombotic complications (3.8%, 2.2%, 0%; P=0.569), access rethrombosis (7.6%, 13%, 12.5%; P=0.517), and tunneled dialysis catheter placement (11.4%, 13%, 12.5%; P=0.958). After excluding procedures performed during a nonaccess-related admission, length of stay (LOS) was highest among HB (9.6±7.8days) compared with SW (2.6±5.9days) and CW (1±2.8days), (P<0.0001). CW therapy in patients undergoing fistulograms was not associated with increased morbidity and was associated with shorter LOS. Bridging with heparin is not associated with improved outcomes, warranting a thorough consideration of continuing warfarin is safe and may streamline preservation of dialysis accesses without significantly increasing resource utilization.

Peri-procedural Outcomes in Patients On Chronic Anticoagulation Undergoing Fistulograms

The management of anti-thrombotic therapy with warfarin in patients undergoing fistulograms and possible interventions is controversial and can be difficult due to lack of adequate outpatient bridging options. Our goal was to assess peri-procedural outcomes of patients with different anticoagulation management strategies undergoing fistulogram.

The Peri-Operative Management of Anticoagulants: Systemic Review of Guidelines

Introduction Venous thromboembolism (VTE) and atrial fibrillation are thrombotic disorders resulting in significant morbidity and mortality, if left untreated. In Canada, 45,000 people, or 1-2 cases per 1000 people, per year will experience an acute VTE, and it is estimated that 200,000 Canadians have atrial fibrillation. The treatment of VTE and atrial fibrillation often includes the use of anticoagulants. Patients on anticoagulation may need interruption of treatment for surgeries and procedures. To evaluate differences in perioperative anticoagulation management strategies we conducted a systematic review of the peri-operative clinical practice guidelines for anticoagulants. Methods A protocol using the Preferred Reporting Items for Systematic review and Meta-analysis Protocols (PRISMA-P) was developed. Relevant primary clinical practice guidelines were identified using MEDLINE, EMBASE, and guideline-specific databases. All guidelines from the preceding 20 years up to January 11, 2019 were screened. Eligible manuscripts were reviewed by two independent reviewers. Data abstraction was independently completed in duplicate for included guidances and categorized according to thrombotic risks and bleeding risks. Guidances on emergency surgeries were not included for the purposes of this review. Information on anticoagulation interruption, bridging regimens, laboratory testing, and reversal strategies were collected. Results Eight guidelines met inclusion criteria and 6 contained sufficient information for peri-operative management of anticoagulants. One guideline focused on patients presenting with bleeding events and restated the same peri-operative guidelines as had been published a year prior by the same group, and was excluded. Another guideline only addressed emergency surgeries and was also excluded from this review. The majority of the guidelines had similar definitions of risk factors for venous and arterial thrombotic events (see table 1). There were no conflicting guidance recommendations identified, but there were differences in the component of peri-operative management addressed by each guideline, ie bridging, reversal agents, laboratory tests. The levels of evidence used to develop recommendations varied between guidelines. All guidelines provided recommendations on warfarin and low molecular weight heparins (LMWH) management and only one guideline provided suggestions for direct oral anticoagulants (DOACs). The findings for perioperative anticoagulation management for patients with atrial fibrillation and VTE are presented in Tables 2 and 3, respectively. For high bleeding risk surgeries, most guidelines cited similar studies resulting in similar recommendations for interruption of warfarin and bridging in high venous and arterial thrombotic risk patients. In high bleeding risk procedures and low thrombotic risk patients, no bridging is recommended. For low bleed risk procedures, regardless of thrombotic risk, guidelines recommended for continuation of anticoagulant therapy. Discussion This systematic review identified 6 guidelines of non-urgent peri-operative management recommendations of primarily warfarin and LMWH in patients with VTE and atrial fibrillation. While no major discrepancies in the guideline suggestions were noted, the scope of data examined (medication management, bridging, blood tests, reversal of agents) differed amongst the various agencies. The guidelines that were most consistent for recommendations of anticoagulant management and bridging tended to be from hematologic societies. The only guideline that addressed perioperative management of DOACs was the 2018 ASH guideline on management of VTE which was against measurement of DOAC levels prior to procedures. The lack of thorough guidance for DOACs is likely due to the year of publication of the guidelines examined and paucity of contributing studies. In terms of reversal agents, all clinical practice guidelines except for the ASH guidelines were prior to specific DOAC reversal agents such as idaracizumab. Future Directions We anticipate that there will be other guidelines developed that address specifically the use of DOACs in the perioperative setting, as well as their reversal agents. Disclosures Shivji: BMS-Pfizer Thrombosis Canada: Other: Fellowship award. Castellucci:BMS: Honoraria; Pfizer: Honoraria; Bayer: Honoraria; LEO Pharma: Honoraria; Sanofi: Honoraria; Aspen: Honoraria; Servier: Honoraria.

Is vessel narrowing secondary to pediatric deep neck space infections of clinical significance?

IntroductionPediatric deep neck space infections (DNSI) may cause internal jugular vein and/or carotid artery narrowing. Radiologists and otolaryngologists are often queried by emergency room providers and pediatricians with regards to the clinical significance when this radiographic finding is noted. There are often questions raised about need for further imaging, anticoagulation and overall management strategy. There is limited data to support our answers to these questions. This study investigated the clinical significance of vessel narrowing of the internal jugular vein and carotid artery in the setting of DNSI in children. Methods208 patients over a 10 year period were reviewed in retrospective fashion. CT scans reports were evaluated for vessel narrowing, and clinical outcomes were analyzed. ResultsThis study found that nearly half (44.7%, 93 of 208) of pediatric DNSIs reviewed showed evidence of either carotid and/or internal jugular vein narrowing. There was no significant difference in vascular complications in those with vessel narrowing and those without (p = 0.09). There were no observed neurologic complications in either group. ConclusionsVessel narrowing is a very common finding in pediatric DNSI. Vascular complications are very rare, and importantly no patients had neurologic complications in either group (vessel narrowing or not). We found no evidence to support more aggressive surgical management, getting further imaging, starting anticoagulation, nor changing overall management strategy for patients based solely to the finding of vessel narrowing in DNSI.

A retrospective analysis of the periprocedural management of oral anticoagulants in patients undergoing interventional radiology procedures.

Limited evidence is available to guide periprocedural management of oral anticoagulants in the setting of interventional radiology (IR) procedures. For direct oral anticoagulants, therapy interruption (TI) is based on medication half-life and procedural bleeding risk. Periprocedural management of warfarin includes INR monitoring, and possible bridging with parenteral anticoagulants. It is unknown if these recommendations apply to IR procedures. To evaluate bleeding complications and thromboembolic events following periprocedural management of the factor Xa (FXa) inhibitors or warfarin in patients undergoing IR procedures. We performed a retrospective, observational study at NYU Langone Health (NYULH) of all adult patients who underwent an IR procedure from January 2015 to July 2017 and were receiving apixaban, rivaroxaban, or warfarin. Patients who were pregnant or who had a mechanical heart valve were excluded. At NYULH, TI is not required for FXa inhibitors, and an INR < 3 is recommended for patients on warfarin undergoing low risk procedures. For moderate/high risk procedures, TI for 48h or 72h with reduced renal function, is recommended for FXa inhibitors, and an INR < 1.5 is recommended for patients on warfarin. We evaluated 350 IR procedures, with a total of 174 low bleeding risk and 176 moderate/high bleeding risk. The 30-day major bleeding rate was 0.9%, clinically relevant non-major bleeding rate was 3%, minor bleeding rate was 1% and thromboembolic event rate was 1%. The periprocedural oral anticoagulation management strategy at NYULH appears safe given the low 30-day incidence of bleeding and thromboembolic events.

Anticoagulation Management during First Five Days of Infant-Pediatric Extracorporeal Life Support

Anticoagulation during infant-pediatric extracorporeal life support (ECLS) has been a topic of study for many years, but management of anticoagulation is still only partially understood. Adequate anticoagulation during ECLS is imperative for successful outcomes and understanding the individual variables that play part is crucial for properly implementing anticoagulation management strategies. The purpose of our study was to compare the relationships between the variables of activated partial thromboplastin time (aPTT), activated clotting time, international normalized ratio, bleeding, thrombus formation, kaolin + heparinase thromboelastograph alpha angle, kaolin thromboelastograph reaction time (KTEG R-time), heparin dose rates (HDR), antithrombin (AT), anti-Xa, bivalirudin dose rate, argatroban dose rate, interventions, and transfusions. We hypothesized that the relationship between measures of anticoagulation would be influenced by the AT levels, and a therapeutic aPTT (60–80 seconds) could be achieved by increasing, or maintaining, the overall AT above a specific threshold for infant-pediatric patients on ECLS. Thirty-five infant-pediatric patients underwent ECLS between January 2013 and January 2016. The median age was 39 days with an average weight of 3.9 ± 4.3 kg. ECLS parameters collected at least every 24 hours for the first five ECLS days. Parameters recorded by retrospective chart review were analyzed using linear regression and receiver operator characteristic (ROC) analysis. We were unable to report a significant correlation between optimal aPTT and HDR at various AT levels. However, ROC analysis suggested that to maintain an aPTT above 60 seconds, an AT threshold of 42% or higher was observed when the HDR was &gt;12 U/kg/h ROC analysis also determined that no thrombus was associated with an aPTT &gt;64 seconds and decreased bleeding was associated with a KTEG R-time below 30 minutes. Based on these findings, we report multiple correlations that may help develop future standardized infant-pediatric ECLS anticoagulation protocols.

A bioprosthetic total artificial heart for end-stage heart failure: Results from a pilot study

The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.