Anticoagulation Management Research Articles

Preventative and curative treatment of venous thromboembolic disease in cancer patients

Cancer-associated venous thromboembolism (CAT) is common in patients with cancer and associated with significant morbidity and mortality. The incidence of CAT continues to rise, complicating patient care and burdening healthcare systems. Patients with cancer experiencing VTE face poorer prognoses, making prevention and effective management imperative. This narrative review synthesizes evidence on thromboprophylaxis in ambulatory patients with cancer receiving systemic therapy and acute treatment strategies for CAT. Risk assessment models (e.g., Khorana score) aid in identifying high-risk patients who may benefit from thromboprophylaxis. Pharmacological thromboprophylaxis with low molecular weight heparins (LMWHs) direct oral anticoagulants (DOACs) has been shown to reduce the risk of CAT without significantly increasing the risk of bleeding complications. However, implementation of risk-based strategies remains limited in clinical practice. For acute CAT management, LMWHs have been the standard of care, but DOACs are increasingly favored due to their convenience and efficacy. However, challenges persist, including bleeding risks and drug interactions. Emerging therapies targeting Factor XI inhibitors present promising alternatives, potentially addressing current limitations in anticoagulation management for CAT.

Anticoagulation for Minimally Invasive Glaucoma Surgery: An American Glaucoma Society Survey

Precis: Perspectives and practice patterns regarding perioperative anticoagulation management and minimally invasive glaucoma surgery were queried among surgeons of American Glaucoma Society. Management varied based on surgeon preference and type of procedure performed. Purpose: The purpose of this study was to characterize anticoagulation and antiplatelet practice patterns for minimally invasive glaucoma surgery (MIGS) in the perioperative period. Materials and Methods: This was a survey of surgeons of American Glaucoma Society (AGS) about anticoagulation decision-making for their most performed MIGS procedures. Results: A total of 103 surgeons completed the survey, with 43.6% in an academic setting, 49.5% in a private practice setting, and 6.8% in a mixed practice. Median MIGS per month was 10 (IQR 20-5). The two most performed MIGS were trabecular meshwork (TM) bypass with either device implantation (24.9%) or tissue excision (40.0%). Half of respondents (50.5%) deferred to the primary care physician about anticoagulation most/all the time. Most (59.3%) managed anticoagulation differently for MIGS compared to trabeculectomy and tube implantation. Respondents reported an average of 1.3 (SD 2.5) bleeding complications related to anticoagulation and MIGS in the last year. Bleeding risk perception depended upon the type of surgery (e.g., 74.0% reported no/mild concern regarding surgeries involving TM bypass with device implantation vs. 48.0% reported high concern for TM bypass with tissue excision). Respondents stopped blood thinners at the highest rates for procedures enhancing aqueous outflow through the subconjunctival space and stopped least frequently for iStent implantation. Antiplatelets were held for a longer duration than anticoagulants prior to surgery, and most resumed both agents within 1–4 days after surgery. Conclusions: Anticoagulation management is highly varied, and this study may help to inform practice guidelines and optimize surgical outcomes by elucidating surgeon perspectives toward MIGS and anticoagulation management.

Perioperative direct oral anticoagulant management during cardiac implantable electronic device surgery: an updated systematic review and meta-analysis.

Patients undergoing cardiovascular implantable electronic device (CIED) implantation are often on direct oral anticoagulation (DOAC). However, the evidence on whether to continue or temporarily discontinue DOAC therapy during the perioperative period in these patients is unclear. We conducted a comprehensive literature review using PubMed, Embase, and Cochrane databases through July 2024. We included studies comparing uninterrupted versus interrupted perioperative DOAC therapy in patients undergoing CIED procedure- primary implants, pulse generator replacement, and device upgrades. Primary outcomes were clinically significant device-pocket hematoma and thromboembolic events. Secondary outcomes included any device-pocket hematoma, all-cause mortality, major bleeding, and any bleeding. A total of 1,607 patients from 8 studies were included. The mean age was 73.2years, with atrial fibrillation as the indication for DOAC therapy in most patients. The mean CHA2DS2-VASc was 3.4. Among the included studies, 2 were randomized control trials (RCTs), while the others were observational cohort studies, including one that was propensity score matched. Our meta-analysis found both strategies to be similar in terms of clinically significant pocket hematoma (RR 1.70; 95%CI 0.84-3.45; p = 0.14; I2 = 0%), thromboembolic complications (RR 0.35; 95%CI 0.04-3.32; p = 0.36; I2 = 19%), any pocket hematoma, all-cause mortality and any bleeding with a higher risk of major bleeding with uninterrupted anticoagulation. This meta-analysis shows that uninterrupted DOAC therapy is comparable to interrupted therapy for CIED procedures, with a potential increase in major bleeding risk but low overall complication rates. Further research is needed to confirm the best approach of periprocedural anticoagulation in these patients.

Current Real-World Status of Oral Anticoagulant Management in Japanese Patients

Current Real-World Status of Oral Anticoagulant Management in Japanese Patients

Systemic Coagulation Derangement as an Early Sign of Oxygenator Failure in Veno-Venous Extracorporeal Membrane Oxygenation (VV ECMO) Without Anticoagulation

Background and Clinical Significance: Veno-venous extracorporeal membrane oxygenation (VV ECMO) has become a widely accepted supportive treatment for severe acute respiratory distress syndrome (ARDS) in intensive care units (ICUs). Although it has gained popularity, some of its aspects, including optimal anticoagulation management and the best means of monitoring hemostasis, remain unresolved. Thrombosis and bleeding are still important complications of ECMO. Case Presentation: A 44-year-old male patient, with no underlying conditions, was diagnosed with severe acute respiratory distress syndrome (ARDS) due to AH1N1 influenza. He presented severe hypoxemia despite the use of mechanical ventilation, neuromuscular blocking agent infusion and prone position. VV ECMO was used, and coagulation was stopped on ECLS day 6 due to severe pulmonary hemorrhage. The systemic hemostatic disorders found in this patient were difficult to differentiate from disseminated intravascular coagulation (DIC) or sepsis-induced coagulopathy (SIC), improved transiently after circuit exchange, and resolved only after discontinuation of ECMO. The patient was discharged fully conscious and cooperative, with no apparent neurological deficit. Conclusions: Systemic hemostatic abnormalities may precede oxygenator failure and mimic DIC or SIC. Timely oxygenator exchange may therefore be considered. However, it is a high-risk procedure, especially in fully ECLS-dependent patients.

An evaluation of the impact of the Lambeth PCN pharmacist anticoagulation skills development project

Abstract Background Atrial Fibrillation (AF) is a prevalent heart condition linked to significant morbidity and mortality due to its association with stroke.1 Despite the clear benefits of anticoagulation in reducing stroke risk, its underuse and suboptimal monitoring remain a concern.2 Aim This study aims to evaluate the impact of a pharmacist-led training programme in Lambeth, London, focusing on improving pharmacists' competency and confidence in managing Direct Oral Anticoagulants (DOACs). It assesses if the training met pharmacists' needs, evaluates current monitoring patterns to determine if training was warranted, and identified areas for further training improvement. Methods The study involved 41 GP practices across 9 Primary Care Networks (PCNs) in Lambeth. Practices were eligible based on their involvement in the management of AF patients prescribed DOACs. All pharmacists at these practices who were actively engaged in anticoagulation management and willing to participate in pre- and post-training assessments were invited to take part. Recruitment involved direct communication through practice managers and emails detailing the study’s objectives and benefits. DOAC monitoring data was extracted from patient medication records and subsequently compared to the South East London anticoagulation guidelines3 to establish compliance percentages. A competency assessment was conducted on pharmacists using a pre- and post-training checklist framework devised by the Consultant Anticoagulant Team at Guy’s and St Thomas’ NHS Foundation Trust (GSTT). The Wilcoxon signed-rank test analysed this paired data, with a p < 0.05 set for statistical significance. Additionally, semi-structured interviews were conducted to gather insights on their training experience and perceptions. Transcripts were coded using NVIVO software to identify themes. Ethical approval was obtained from Kingston University London. Results Of the 2,987 AF patients across the 41 GP practices, 87.6% were on DOACs. Prescribing and monitoring trends were consistent across all GPs, with scope to improve compliance across all parameters, such as CHA₂DS₂-VASc score assessment prior to DOAC initiation. The competency assessment, completed by ten pharmacists, showed a significant improvement post-training, with mean scores rising from 3.3 to 4.1 (p< 0.00001). Improvements were seen across all domains, particularly in explaining the rationale for anticoagulation, showing CHA₂DS₂-VASc and HASBLED scores, and discussing modifiable HASBLED factors. Competency in patient communication remained highest, while managing particular cases like reversal procedures and patients with cancer showed lower competency, indicating areas for training improvement. The interviews, conducted with ten pharmacists, revealed three main themes: (1) Confidence and competence in anticoagulant prescribing and optimisation, (2) Evaluation of the training programme's effectiveness, and (3) Professional growth and career development. Pharmacists reported greater confidence in managing DOACs post-training, though challenges remained in patient engagement and collaboration with GPs lacking DOAC knowledge. Discussion / Conclusion The evaluation proved a positive impact on pharmacists' competency and confidence in DOAC management. Suboptimal monitoring practices in Lambeth highlighted the need for this training programme and its crucial role in improving patient outcomes. Limitations include a small interview sample and potential biases in self-reported evaluations. A longitudinal study is recommended to assess long-term impacts. Ongoing training and systematic data collection are essential, and similar training should be extended to other healthcare professionals.

System-Wide, Electronic Health Record-Based Medication Alerts for Appropriate Prescribing of Direct Oral Anticoagulants: Pilot Randomized Controlled Trial.

While direct oral anticoagulants (DOACs) have improved oral anticoagulation management, inappropriate prescribing remains prevalent and leads to adverse drug events. Antithrombotic stewardship programs seek to enhance DOAC prescribing but require scalable and sustainable strategies. We present a pilot, prescriber-level randomized controlled trial to assess the effectiveness of electronic health record (EHR)-based medication alerts in a large health system. The pilot assessed prescriber responses to alerts for initial DOAC prescription errors (apixaban and rivaroxaban). A user-centered, multistage design process informed alert development, emphasizing clear indication, appropriate dosing based on renal function, and drug-drug interactions. Alerts appeared whenever a DOAC was being prescribed in a way that did not follow package label instructions. Clinician responses measured acceptability, accuracy, feasibility, and utilization of the alerts. The study ran from August 1, 2022, through April 30, 2023. Only 1 prescriber requested trial exclusion, demonstrating acceptability. The error rate for false alerts due to incomplete data was 6.6% (16/243). Two scenarios with alert design and/or execution errors occurred but were quickly identified and resolved, underlining the importance of a responsive quality assurance process in EHR-based interventions. Trial feasibility issues related to alert-data capture were identified and resolved. Trial feasibility was also assessed with balanced randomization of prescribers and the inclusion of various alerts across both medications. Assessing utilization, 34.2% (83/243) of the encounters (with 134 prescribers) led to a prescription change. The pilot implementation study demonstrated the acceptability, accuracy, feasibility, and estimates of the utilization of EHR-based medication alerts for DOAC prescriptions and successfully established just-in-time randomization of prescribing clinicians. This pilot study sets the stage for large-scale, randomized implementation evaluations of EHR-based alerts to improve medication safety. ClinicalTrials.gov NCT05351749; https://clinicaltrials.gov/study/NCT05351749.

Association Between Direct Oral Anticoagulant Score and Bleeding Events in Patients With Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: A Retrospective Multicenter Cohort Study.

The Direct Oral Anticoagulant (DOAC) Score can predict bleeding risk in patients with atrial fibrillation taking DOACs; however, it lacks external validation. Therefore, this study aimed to assess the association between the DOAC Score and bleeding events in patients with atrial fibrillation who underwent transcatheter aortic valve replacement. This retrospective multicenter cohort study included patients with atrial fibrillation who underwent transcatheter aortic valve replacement, as registered in a Japanese multicenter registry. The primary end point was the incidence of bleeding. Patients were categorized based on their DOAC Score: low and moderate- (≤7 points), high- (8-9 points), and very high-risk (≥10 points) groups. Among 1230 patients (mean age 84.6±5.1 years; 457 men), 465 (37.8%) received a vitamin K antagonist, and the remaining patients received DOACs. The low and moderate-, high-, and very high-risk groups included 380 (30.1%), 497 (40.4%), and 353 patients (28.7%), respectively. The 3-year cumulative incidence of all bleeding events was significantly different among the 3 groups (low and moderate risk: 6.6%, high risk: 6.9%, and very high risk: 14.0%; P<0.01). Multivariable Cox regression analysis revealed that significant increments in the DOAC Score were associated with a risk of all bleeding events at 3 years in the overall cohort (hazard ratio [HR], 1.22 [95% CI, 1.08-1.38]; P<0.01), in the DOAC cohort (HR, 1.20 [95% CI, 1.01-1.42]; P=0.04), and in the vitamin K antagonist cohort (HR, 1.25 [95% CI, 1.04-1.50]; P=0.02). The DOAC Score was significantly associated with bleeding events in patients with atrial fibrillation after transcatheter aortic valve replacement, aiding in clinical decision-making for anticoagulant management. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023585; Unique identifier: UMIN000020423.

Haemorrhagic and thromboembolic outcomes in pregnant patients with mechanical heart valves who undergo interruption of anticoagulation for birth - A case series.

Anticoagulant therapy prevents thrombosis and thromboembolic events in patients with mechanical heart valves. Bridging anticoagulation around the time of birth represents a unique challenge. Few retrospective reviews or case series exist examining peripartum outcomes with bridging anticoagulation. Review of peripartum and postpartum anticoagulation management, with a focus on postpartum complications. Design: case series, single centre. Royal Brisbane and Women's Hospital, Australia between 1 January, 2000, and 1 August, 2022. all pregnant women with mechanical heart valves (any type) who birthed. intrapartum and postpartum haemorrhage, thrombosis, thromboembolic complications, cardiac events, readmission, and maternal death. There were 18 women, with 23 births. Sixteen births were via caesarean section (70%). Fourteen women (61%) experienced at least one significant haemorrhagic complication, one woman required a peripartum hysterectomy, one woman experienced atrial fibrillation, and one had a valvular thromboembolic complication. No maternal cerebral thromboses or maternal deaths were recorded. Women with mechanical heart valves who undergo bridging anticoagulation are associated with significant maternal morbidity. Most postpartum haemorrhagic complications were associated with bridging unfractionated heparin infusions in the first postnatal week. Bridging anticoagulation practices varied widely. Ongoing pooled data are required to inform evidence-based guidelines for postpartum anticoagulation management.

Breaking boundaries: exploring recent advances in anticoagulation and thrombosis management: a comprehensive review.

Thromboembolic disorders globally contribute to morbidity and mortality, emphasizing adequate anticoagulation and thrombosis management. Therapeutic advances are essential in preventing complications like pulmonary embolism, stroke, and myocardial infarction. This review summarizes recent anticoagulation advances, current challenges, future directions, and novel anticoagulants and drug delivery systems on clinical outcomes. This paper assesses the effectiveness and safety of new anticoagulants through a systematic review of recent clinical trials, meta-analyses, and guideline publications. Key studies, including PACIFIC-AF, RIVER, ENAVLE, ENVISAGE-TAVI AF, and ARCADIA, were analyzed to provide a perspective on therapeutic advancements. The review highlights key findings from vital clinical trials. Asundexian, in the PACIFIC-AF trial, demonstrated a 34% reduction in bleeding events compared to Apixaban. In the RIVER trial, Rivaroxaban reduced significant bleeding events by 20% compared to warfarin in patients with bioprosthetic mitral valves. In the ENAVLE trial, Edoxaban achieved a 3.7% decrease in thromboembolic events compared to warfarin without increasing significant bleeding rates. In the ENVISAGE-TAVI AF trial, edoxaban was noninferior to VKAs in preventing thromboembolic events but showed a slight increase in major bleeding events by 1.5%. Lastly, the ARCADIA trial highlighted that apixaban did not significantly reduce recurrent stroke risk compared to aspirin, with both treatments having an annualized stroke rate of 4.4%. Advances in anticoagulant therapies and drug delivery systems aim to enhance patients' clinical outcomes for thromboembolic disorders. While recent trials show promising data, ongoing patient-specific responses and monitoring challenges require further research. Continuous innovation and investigation are essential to refine anticoagulation practices and tailor treatments.

Anticoagulation management in gynecologic brachytherapy patients with perioperative or chronic thromboembolic disease: A retrospective analysis

Women on chronic anticoagulation (AC) who require operative brachytherapy for gynecologic malignancies represent a clinical challenge, but no guidelines exist regarding patient selection for brachytherapy or their perioperative management. We aimed to understand the incidence of hemorrhagic and embolic events in our patients on chronic AC and suggest management strategies for this patient population. A retrospective, single institutional study of patients treated with operative, gynecologic brachytherapy from 2013 to 2023 was performed to identify patients on chronic AC. We determined indications for AC use, oncologic therapy characteristics, duration of AC interruption, and therapy outcomes. The primary aim was to determine perioperative embolic or hemorrhagic complications as measured by the Common Terminology Criteria for Adverse Events. Of 304 patients treated with operative implants, 32 (10%) were on chronic AC for venous thromboembolism (n = 25), or atrial fibrillation/flutter (n = 13). The most common malignancies were cervical (n = 15) and inoperable uterine (n = 11). Implants were intracavitary (n = 14), interstitial (n = 6), or hybrid (n = 12) with a median (range) of 2 (1-3) implants, 4 (2-5) fractions, and 2 (1-3) days of bedrest per implant. 63% (n = 20) had an epidural for analgesia. AC was held for a median 3 days in 94% (n = 30) prior to the operative implant, and pharmacologic DVT prophylaxis was used in 78% (n = 25). There were two grade ≥ 2 hemorrhagic events and no new embolic events. The rate of bleeding and embolic events was acceptable, and women on chronic AC should not be excluded from potentially lifesaving operative brachytherapy, including complex cases that require spinal analgesia and interstitial applicators.

Effectiveness of a self-management program for anticoagulated patients to improve their knowledge about treatment and time in therapeutic range.

Oral anticoagulation self-control programs have demonstrated efficiency and cost-effectiveness over recent years. This study aimed to evaluate the effectiveness of a training intervention focused on patients with antivitamin K anticoagulants included in a self-care program. For this, we made a quasi-experimental study, pretest and post-test, using a validated questionnaire with 2 measures, before and after an educational intervention about oral anticoagulation focused on patients that will initiate the self-control program in consultation. To check the patient's adherence and coagulation level, we evaluated the Rosendaal time in therapeutic rank, both before and after the intervention. One hundred fifty patients were included since the start of the self-monitoring program in our center in 2016. The mean age was 49 years (standard deviation [SD] = 17.24). The distribution by gender was 76 women and 69 men (52.4%-47.6%). The mean score for the first test was 14.61 (SD = 3.26) and the mean score for the second test was 17.01 (SD = 2.14) (P <.001). We also measured Rosendaal time in therapeutic rank, a parameter that indicates stabilization in international normalized ratio determinations and quality of the anticoagulation management. Values before and after interventions were also statistically significant (67.46 vs 70.53, P <.001). Patients' knowledge improved after the training session, with statistical significance. Despite intentional sampling, the population was homogeneous. Scoring data dispersion in the second test was significantly lower than in the first one. Time on therapeutic rank values was better after the training. We intend to adapt its content to the rest of anticoagulated patients to enhance and improve their follow-up.

Anticoagulation control challenges in patients with rheumatic heart disease and mechanical heart valves operated at a cardiac surgery center in a low-income country

Abstract Background Rheumatic heart disease (RHD) prevalence is very high in many low-income countries and valve replacement surgery can sometimes be the only available therapeutic strategy for the affected patients. Mechanical valves require lifelong anticoagulation and this can be very challenging in many poor countries where several barriers to effective anticoagulation monitoring and management are faced. Methods This is a retrospective study on 145 patients with RHD who underwent valve replacement surgery at a cardiac surgery center (CSC) in a low-income country between 2001 and 2022. The study aimed to evaluate the effectiveness of anticoagulation treatment to prevent thromboembolic events in patients with RHD with mechanical valves. The patients’ information such as social and demographic data, clinical features, surgical data and international normalized ratio (INR) records were collected and analyzed. Descriptive statistics were applied to the data and expressed as mean with standard deviation or simple frequencies and percentages. Results The mean age of the operated patients was 25.9 years (± 12.6) and 60% of them were female. Most of the patients (54%) were able to monitor their anticoagulation at the center and 8.2% of them monitored it in other hospitals. Three percent (3%) of the patients use a portable device to monitor their INR. These devices are provided by the CSC to help patients that live in distant provinces and are unable to go to the capital regularly. The device is held by one patient that is a focal point and helps monitor the INR of the other patients living in the same province. The INR results are communicated to the CSC by telephone text message. Seven percent (7%) of the operated patients haven’t monitored their INR for more than one year and 24.8% of them were lost to follow-up. Sixty-four percent (64%) of the patients who monitor their INR at the center have an optimal control of their anticoagulation therapy. Most of the patients that were lost to follow-up (N=20) and most of the patients that haven’t checked their INR for more than one year (N=7) are patients who had aortic valve replacements. At least 20% of the patients that live in capital of the country and close to the CSC don’t monitor their anticoagulation regularly. Conclusion The surgical outcomes in RHD patients who undergo mitral valve repair are usually satisfactory. However, valve replacement is often the only feasible alternative and anticoagulation monitoring and management in these patients can become a serious problem especially to those coming from areas with limited resources. Illiteracy and poverty play a major role as barriers to effective monitoring of anticoagulation therapy. Efforts must be made to increase access to facilities where INR can be monitored. Our experience showed us that providing portable devices for INR monitoring to the patients living in remote areas can be a favorable short-term solution.

European practices on antithrombotic management during percutaneous mechanical circulatory support in adults: insights from an international survey

Abstract Background Bleeding and thrombotic complications remain a major concern in cardiogenic shock (CS) patients undergoing percutaneous mechanical circulatory support (pMCS) with veno-arterial extracorporeal membrane oxygenation (V-A ECMO) and/or microaxial flow pumps like the Impella. Antithrombotic practices strongly determine the coagulopathic risk, but standardized protocols are lacking in this context. Purpose This survey outlines European practices on antithrombotic management in adults on pMCS for CS, making an initial effort to standardize practices, inform future trials, and enhance outcomes. Methods This online cross-sectional survey was distributed through digital newsletters and social media platforms by the Association of Acute Cardiovascular Care (ACVC) of the ESC and the European branch of the Extracorporeal Life Support Organization (EuroELSO). The survey was accessible from April 17th to May 23rd, 2023. The target population were European clinicians involved in care for adults on pMCS. Results We included 105 responses from 26 European countries. In 72.4% of the European respondents’ institutions, a standardized local anticoagulation protocol is present, with unfractionated heparin (UFH) being the predominantly used anticoagulant (Impella: 97.0%; V-A ECMO: 96.1%). Similarly, the purge solution during Impella support is most frequently UFH-based (84.1%). A bicarbonate-based purge solution (BBPS) as standard purge is reported by only 1.6%. UFH titration based on the activated partial thromboplastin time (APTT) alone is the most common practice either for Impella (43.1%) and for V-A ECMO (32.9%). A minority of 16.9% and 13.2% indicate relying on activated clotting time (ACT) for UFH-titration during Impella and V-A ECMO support, respectively. UFH-titration protocols are anti-Xa based for 12.3% (Impella) and 10.5% (V-A ECMO) of the respondents. An UFH anticoagulant protocol based on APTT and anti-Xa in parallel is the preferred option for 10.8% (Impella) and 14.5% (V-A ECMO) of the respondents. Anticoagulant targets for APTT, ACT and anti-Xa varied across institutions. The majority (83.8%) does not alter their anticoagulation management in case of combined Impella plus V-A ECMO-approach (ECMELLA). Typical thresholds for transfusion or administration of blood products without acute bleeding as indication vary substantially and are frequently not predefined. Following acute coronary syndrome without percutaneous coronary intervention (PCI), 54.0% and 42.7% administered dual antiplatelet therapy during Impella and V-A ECMO support, increasing to 93.7% and 84.0% after PCI. Conclusions Our survey validated the considerable variation in antithrombotic management in adults in CS on pMCS across European centres. There is a pressing demand for a standardized approach to antithrombotic management in this context to mitigate the impact of coagulopathic complications and, consequently, enhance outcomes.Figure 1.Figure 2.

Comparison of interrupted and uninterrupted anticoagulation strategies for cardiac implantable electronic device insertion: a systematic review and meta-analysis

Abstract Introduction Up to 35% of patients who are candidates for a cardiac implantable electronic device (CIED) receive chronic anticoagulation. However, guidelines on anticoagulant management in the perioperative period of CIED insertion differ worldwide. It is uncertain whether interrupting or continuing anticoagulation in these settings provides optimal outcomes. Purpose To assess the effects of interrupting versus continuing chronic anticoagulation with either warfarin or a direct oral anticoagulant (DOAC) in the perioperative setting of CIED insertion. Methods CENTRAL, MEDLINE, Embase, Web of Science, and two trial registries were searched from inception to 26 November 2021. Randomised controlled trials (RCTs) assessing interrupting chronic warfarin or DOAC therapy, with or without heparin bridging, versus continuing anticoagulation in adults undergoing CIED insertion were included. Comparisons were divided into two categories: interrupted versus uninterrupted warfarin and interrupted versus uninterrupted DOAC. Outcomes were expressed as risk ratios (RR) with 95% confidence intervals (95%CI). Inverse variance random-effects models were used for the meta-analyses. Risk of bias (RoB) was assessed using the Cochrane RoB2 tool, and certainty of evidence (CoE) per outcome was assessed with GRADE methods. Results Ten RCTs (n=2221) were included: five RCTs (n=1267) used warfarin; four RCTs (n=954) used DOACs. One additional RCT using warfarin was ongoing without any outcome data available. Bleeding events included device-pocket haematoma, haemothorax, cardiac tamponade, and non-tamponade pericardial effusion. Interrupted versus uninterrupted warfarin: The evidence is very uncertain on the effect of interrupted warfarin on device-pocket haematoma (RR 1.89, 95%CI 0.85 to 4.20, 5 RCTs, very low CoE) and bleeding events (RR 1.94, 95%CI 0.86 to 4.41, 5 RCTs, very low CoE). Interrupted warfarin may result in little to no difference in thromboembolic events (RR 0.85, 95%CI 0.18 to 4.11, 5 RCTs, low CoE) and ischaemic stroke (RR 1.01, 95%CI 0.11 to 9.61, 2 RCTs, low CoE). Interrupted warfarin may reduce all-cause mortality (RR 0.35, 95%CI 0.04 to 2.93, 3 RCTs, low CoE). Interrupted versus uninterrupted DOAC: The evidence is very uncertain on the effect of interrupted DOAC on device-pocket haematoma (RR 1.15, 95%CI 0.58 to 2.28, 4 RCTs, very low CoE) and bleeding events (RR 1.14, 95%CI 0.58 to 2.21, 4 RCTs, very low CoE). Interrupted DOAC may result in little to no difference in thromboembolic events (RR 0.98, 95%CI 0.06 to 15.63, 3 RCT, low CoE) and ischaemic stroke (RR 0.98, 95%CI 0.06 to 15.63, 2 RCTs, low CoE). Interrupted DOAC may reduce all-cause mortality slightly (RR 0.49, 95% CI 0.04 to 5.39, 2 RCTs, low CoE). Conclusion Interrupting anticoagulation with either warfarin or DOACs in patients undergoing CIED insertion produced similar outcomes as uninterrupted anticoagulation.Figure 1.Figure 2.

Optimal anticoagulation strategy for left ventricular assist device patients undergoing thoracentesis: a retrospective study

Abstract Background Left ventricular assist devices (LVADs) are associated with thromboembolic risks necessitating anticoagulation, yet balancing these risks with bleeding concerns remains challenging. Current practice involves warfarin with a target INR of 2-3 alongside anti-platelet therapy. However, consensus on anticoagulation management is lacking, particularly during sub-therapeutic INR or procedural settings. Common strategies include bridging anticoagulation with heparin or enoxaparin, temporary cessation of anticoagulation during the procedure or uninterrupted anticoagulation. Purpose To evaluate and compare the incidence of bleeding and thromboembolic events in LVAD patients undergoing thoracentesis, with a focus on determining the optimal anticoagulation strategy during procedures. Methods Retrospective data was collected over one year from LVAD patients undergoing thoracentesis at a large academic center. Patients were categorized into ‘bridge’ (received intravenous heparin for bridging during thoracentesis) and ‘no-bridge’ (did not receive bridging anticoagulation) groups. Warfarin was paused before procedure and resumed after procedure in both groups. Baseline characteristics, including age, sex, race, BMI, LVAD type, and INTERMACS profile, were recorded. Primary outcomes were major bleeding and thromboembolic events within 30 days of warfarin cessation. Statistical analysis used t-test/Wilcoxon for continuous variables and Chi-square/Fisher exact test for categorical variables. A p-value &amp;lt;0.05 was considered significant. Results During the study, twenty LVAD patients underwent thirty-two thoracenteses (nineteen bridge, thirteen no-bridge). The demographics were similar among the two groups. Warfarin was held for an average of 5.5 ± 4.6 days before and resumed 4.1 ± 4.6 days after the procedure in the bridge group and 3.8± 3.2 days before and 1.7 ± 2.5 days after in the no-bridge group. Major bleeding occurred in 73.7% of bridge group cases versus 30.8% of no-bridge group cases (p=0.059). 63.2% of bridge group patients had a bloody pleural effusion on thoracentesis compared to 46.2% of no-bridge group patients (p value= 0.34). Average transfusion requirements were 2.8 units and 2 units in the bridge and the no-bridge groups respectively (p=0.658). Thromboembolic events included a 10.5% ischemic CVA rate in the bridge group, with none in the no-bridge group. No other arterial thromboembolic events, pump thrombosis or DVT/PE were observed in either group. Conclusion In LVAD patients undergoing thoracentesis, a non-bridging strategy does not appear to elevate the risk of thrombosis compared to a bridging approach. Moreover, the incidence of bleeding, while not statistically significant, trended higher in the bridging group.

GSOR06 Presentation Time: 5:25 PM: Anticoagulation Management in Gynecologic Brachytherapy Patients with Perioperative or Chronic Thromboembolic Disease

GSOR06 Presentation Time: 5:25 PM: Anticoagulation Management in Gynecologic Brachytherapy Patients with Perioperative or Chronic Thromboembolic Disease

Delphi consensus on oral anticoagulation management in special clinical situations in the cardiology setting.

Background: Management of oral anticoagulation (OAC) can be challenging, such as in complex cases of nonvalvular atrial fibrillation (NVAF).Materials & methods: A Delphi study comprising two rounds was used for gathering expert opinion through an online questionnaire (83 items grouped in 8 dimensions) on OAC management in specific clinical settings.Results: Consensus was reached for 79 items (95%) in round 1. Experts recommended direct-acting oral anticoagulants (DOACs) for pericardioversion, uninterrupted OAC for catheter ablation, and dual therapy with a DOAC and clopidogrel after percutaneous coronary intervention. They also recommended restarting OAC with a DOAC after an intracranial haemorrhage.Conclusion: The expert-based recommendations obtained may contribute to standardizing and guiding the management of OAC in complex clinical situations in cardiology.

Strategies for Perioperative Anticoagulant Reversal in Orthopedic Surgery: A Review.

The administration of anticoagulation therapy during major orthopedic surgeries is a clinical challenge due to the risk of thrombotic events and bleeding complications. This review aims to evaluate the current strategies and emerging developments in perioperative anticoagulation reversal. We conducted a literature review on the management of perioperative anticoagulant therapy, which included the current status of anticoagulant reversal agents, as well as personalized medicine, pharmacogenomics, artificial intelligence (AI), and novel drug delivery systems. The review indicates that reversal agents such as idarucizumab and andexanet alfa are crucial in managing bleeding associated with direct oral anticoagulants (DOACs). Personalized medicine, guided by pharmacogenomics, allows for tailored anticoagulation regimens. AI and machine learning (ML) algorithms can enhance the predictive capabilities for bleeding and thrombotic risks. Additionally, nanotechnology and biomarkers offer innovative approaches to drug delivery and personalized treatment. Integrating evidence-based guidelines with innovative reversal agents, personalized medicine, AI and nanotechnology opens a new era in perioperative anticoagulation management. These advancements can ensure patient safety, minimize bleeding risks, and improve surgical outcomes. Future research should focus on the clinical validation of these strategies to ensure their effectiveness across diverse patient populations.

Effect of Unfractionated Heparin Dose on Complement Activation and Selected Extracellular Vesicle Populations during Extracorporeal Membrane Oxygenation.

Extracorporeal membrane oxygenation (ECMO) provides critical support for patients with severe cardiopulmonary dysfunction. Unfractionated heparin (UFH) is used for anticoagulation to maintain circuit patency and avoid thrombotic complications, but it increases the risk of bleeding. Extracellular vesicles (EVs), nano-sized subcellular spheres with potential pro-coagulant properties, are released during cellular stress and may serve as potential targets for monitoring anticoagulation, particularly in thromboinflammation. We investigated the impact of UFH dose during ECMO therapy at the coagulation-inflammation interface level, focusing on complement activation and changes in circulating large EV (lEV) subsets. In a post hoc analysis of a multicenter randomized controlled trial comparing two anticoagulation management algorithms, we examined lEV levels and complement activation in 23 veno-venous-ECMO patients stratified by UFH dose. Blood samples were collected at different time points and grouped into three phases of ECMO therapy: initiation (day 1), mid (days 3-4), and late (days 6-7). Immunoassays detected complement activation, and flow cytometry analyzed lEV populations with an emphasis on mitochondria-carrying subsets. Patients receiving <15 IU/kg/h UFH exhibited higher levels of the complement activation product C5a and soluble terminal complement complex (sC5b-9). Lower UFH doses were linked to increased endothelial-derived lEVs, while higher doses were associated with elevated RBC-derived and mitochondria-positive lEVs. Our findings suggest the potential theranostic relevance of EV detection at the coagulation-inflammation interface. Further research is needed to standardize EV detection methods and validate these findings in larger ECMO patient cohorts.