Periprocedural Anticoagulation Research Articles

Veno-venous extracorporeal membrane oxygenation in devastating bacterial pneumonia: a case report and review of the literature

BackgroundBacterial pneumonia is one of the most common causes of acute respiratory distress syndrome. In fulminant cases, when mechanical ventilation fails, veno-venous extracorporeal membrane oxygenation is required. However, this method is still associated with significant mortality and a wide range of potential complications. However, there are now many case reports of good outcomes even in patients with prolonged extracorporeal oxygenation, as in our rather complicated case report.Case presentationOur case report describes a complicated but successful treatment of a severe, devastating bacterial pneumonia in a 39-year-old European polymorbid woman with a rare form of diabetes mellitus, which had been poorly compensated for a long time with limited compliance, in the context of a combined immunodeficiency that strongly influenced the course of the disease. The patient’s hospitalization required a total of 30 days of veno-venous extracorporeal membrane oxygenation therapy and more than 50 days of mechanical ventilation. Numerous complications, particularly bleeding, required seven chest drains, two extracorporeal membrane oxygenation circuit changes, and one surgical revision. The patient’s mental state required repeated psychiatric intervention.ConclusionIt is possible that even the initially severely damaged lung parenchyma can develop its regenerative potential if suitable conditions are provided for this process, including a sufficiently long period of extracorporeal membrane oxygenation.We believe that this case report may also contribute to the consideration of the indications and contraindications of extracorporeal support. The authors also discuss the limitations and risks of prolonged veno-venous extracorporeal membrane oxygenation support and periprocedural anticoagulation strategies.

Safety and efficacy of anticoagulation therapy post atrial fibrillation ablation

Abstract Funding Acknowledgements None. Background Thromboembolic complications can be life-threatening during atrial fibrillation (AF) catheter ablation. The aim of our single center, retrospective study was to evaluate the safety and efficacy of continuous treatment using direct oral anticoagulants (DOACs) as an alternative to uninterrupted acenocoumarol for periprocedural anticoagulation. Purpose To record the safety and efficacy of the oral anticoagulants post atrial fibrillation ablation. Methods We studied 1999 patients undergoing AF catheter ablation between June 2013 and December 2021 in our center. All patients were assigned to take acenocoumarol (group 1, 194 patients) or DOACs (group 2, 1805 patients) for ≥2 months before the procedure. We compared thromboembolic and bleeding complications between the 2 groups. Results Our analysis showed no significant difference in major and minor complications between the 2 patient groups with the exception of the occurrence of groin hematoma with a clear superiority of DOACs (2.06%-0.5%, p<0.05). Specifically, 4 of 194 patients (2.06%) using uninterrupted acenocoumarol had a major complication (3 patients [1.55%] had transient ischemic attack resolved 8 hours later and 1 [0.52%] had pericardial tamponade, and 7 patients (3.61%) had minor complications (4 [2.06%] groin hematoma and 3 [1.55%] mild pericardial efussion). In group 2, 14 of 1805 patients (0.78%) had a major complication (11 patients had transient ischemic attack (0.61%) and 3 patients (0.17%) had pericardial tamponade). In the same group, 31 patients (1.72%) had a minor complication (3 patients [0.17%] presented with pseudoaneurysm or femoral arteriovenous fistula between the femoral artery and femoral vein, 19 [1.05%] with pericardial effusion <1 cm, and 9 [0.5%] groin hematoma). Conclusions DOACs and acenocoumarol have similar safety and effectiveness regarding thromboembolic complications prevention without increasing bleeding complications with the exception of the occurrence of groin hematoma with a clear superiority of DOACs.

Reduced dementia risk in patients with optimized anticoagulation therapy undergoing atrial fibrillation ablation

BackgroundAtrial fibrillation (AF) is associated with the development of dementia, and observational studies have shown that oral anticoagulation and catheter ablation reduce dementia risk. However, such studies did not consistently report on periprocedural anticoagulation and long-term oral anticoagulation coverage, for which reason the separate effect of AF ablation on dementia risk could not be established. ObjectiveWe evaluated the protective effect of AF ablation in a large cohort of patients who received optimized anticoagulation and compared them with patients who were managed medically. MethodsWe retrospectively included 5912 consecutive patients who underwent first-time catheter ablation for AF between 2008 and 2018 and compared them with 52,681 control individuals from the Swedish Patient Register. Propensity score matching produced 2 cohorts of equal size (n = 3940) with similar baseline characteristics. Dementia diagnosis was identified by International Classification of Diseases codes from the patient register. ResultsMost propensity score–matched patients were taking an oral anticoagulant at the start (94.5%) and end (75.0%) of the study. Mean follow-up was 4.9 ± 2.8 years. Catheter ablation was associated with lower risk for the dementia diagnosis compared with the control group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.22–0.86; P = .017). The result was similar when including patients with a stroke diagnosis before inclusion (HR, 0.50; 95% CI, 0.28–0.89; P = .019) and after adjustment for the competing risk of death (HR, 0.41; 95% CI, 0.20–0.86; P = .018). ConclusionCatheter ablation of AF in patients with optimized oral anticoagulation therapy was associated with a reduction in dementia diagnosis, even after adjustment for potential confounders and for competing risk of death.

Periprocedural Anticoagulation Management of Patients Undergoing Colonoscopy with Polypectomy.

Introduction/Objective Colonoscopy with polypectomy is an integral component of colorectal cancer screening. There are limited data and consensus on periprocedural anticoagulation management, especially regarding bleeding risk with uninterrupted anticoagulation and thromboembolic risk with interruption. Our aim was to determine the incidence of bleeding and thromboembolic complications among colon screening participants undergoing colonoscopy following implementation of a novel patient care pathway for standardized periprocedural anticoagulation management. Methods We conducted a retrospective study including all participants (age 50-74) on an oral anticoagulant (e.g., vitamin K antagonists, direct oral anticoagulants) referred to the British Columbia Colon Screening Program for colonoscopy following abnormal fecal immunochemical test in a 6-month period (March-August 2022). Data relating to their specific periprocedural anticoagulant management and colonoscopy results including method of polypectomy were obtained. Primary outcomes were major bleeding and arterial or venous thromboembolic events from time of oral anticoagulant interruption until 14 days of postcolonoscopy. Secondary outcomes included nonmajor and minor bleeding, acute coronary syndrome, emergency room visit, hospital admission, and death due to any cause. Results Over the 6-month period, 162 participants completed standardized periprocedural anticoagulation management, colonoscopy ± polypectomy, and 14-day follow-up. One (0.6%) had a major bleeding event and one (0.6%) had an arterial thromboembolic event. Conclusions A novel patient care pathway for standardized periprocedural anticoagulation management with a multidisciplinary team is associated with low rates of major bleeding and thrombotic complications after colonoscopy with polypectomy.

In-Hospital Pulmonary Arterial Embolism after Catheter Ablation of Over 45,000 Cardiac Arrhythmias: Individualized Case Analysis of Multicentric Data.

Data on incidence of in-hospital pulmonary embolisms (PE) after catheter ablation (CA) are scarce. To gain further insights, we sought to provide new findings through case-based analyses of administrative data. Incidences of PE after CA of supraventricular tachycardias (SVT), atrial fibrillation (AF), atrial flutter (AFlu), and ventricular tachycardias (VT) in three German tertiary centers between 2005 and 2020 were determined and coded by the G-DRG (German Diagnosis Related Groups System) and OPS (German Operation and Procedure Classification) systems. An administrative search was performed with a consecutive case-based analysis. Overall, 47,344 ablations were analyzed (10,037 SVT; 28,048 AF; 6,252 AFlu; 3,007 VT). PE occurred in 14 (0.03%) predominantly female (n = 9; 64.3%) patients with a mean age of 55.3 ± 16.9 years, body mass index 26.2 ± 5.1 kg/m2, and left ventricular ejection fraction of 56 ± 13.6%. PE incidences were 0.05% (n = 5) for SVT, 0.02% (n = 5) for AF, and 0.13% (n = 4) for VT ablations. No patient suffered PE after AFlu ablation. Five patients (35.7%) with PE after CA had no prior indication for oral anticoagulation (OAC). Preprocedural international normalized ratio in PE patients was 1.2 ± 0.5. Most patients with PE following CA presented with symptoms the day after the procedure (n = 9) after intraprocedural heparin application of 12,943.2 ± 5,415.5 IU. PE treatment included anticoagulation with either phenprocoumon (n = 5) or non-vitamin K-dependent OAC (n = 9). Two patients with PE died after VT/AF ablation, respectively. The remaining patients were discharged without sequels. Over a 15-year period, incidence of PE after ablation is low, particularly low in patients with ablation for AF/AFlu. This is most likely due to stricter anticoagulation management in these patients compared with those receiving SVT/VT ablation procedures and could argue for continuation of OAC prior to ablation. Optimizing periprocedural anticoagulation management should be subject of further prospective trials.

Strategies to reduce rates of severe endothermal heat-induced thrombosis following radiofrequency ablation

ObjectiveEndothermal heat-induced thrombosis (EHIT) is a potential complication of radiofrequency ablation (RFA). Data on effective prophylaxis of EHIT are limited. In 2018, a high-volume, single institution implemented strategies to decrease the incidence of EHIT, including a single periprocedural prophylactic dose of low-molecular-weight heparin to patients with a great saphenous vein (GSV) diameter of ≥8 mm or saphenofemoral junction (SFJ) diameter of ≥10 mm and limiting treatment to one vein per procedure. The size threshold was derived from existing literature. The study objective was to evaluate the effects of these institutional changes on thrombotic complication rates after RFA. MethodsA retrospective cohort control study was conducted using the Vascular Quality Initiative database. Data were collected for patients who underwent RFA with a GSV diameter of ≥8 mm or SFJ diameter of ≥10 mm from January 2015 to July 2022. The clinical end points were thrombotic complications (ie, thrombophlebitis, EHIT, deep vein thrombosis) and bleeding complications. Patient demographic and procedural variables were included in the analysis, and significant variables after univariable logistic regression were included in a multivariable logistic regression. ResultsAfter the policy change, the overall vein center EHIT rate decreased from 2.6% to 1.5%, with a trend toward significance (P = .096). The inclusion criterion of a GSV diameter of ≥8 mm or an SFJ diameter of ≥10 mm yielded 845 patients, of whom 298 were treated before the policy change and 547 after. There was a significant reduction in the rate of EHIT classified as class ≥III (2.34 vs 0.366; P = .020) after the institutional changes. Treatment of two or more veins and an increased vein diameter were associated with an increased risk of EHIT (P = .049 and P < .001, respectively). No significant association was found between periprocedural anticoagulation and all-cause thrombotic complications or EHIT (P = .563 and P = .885, respectively). ConclusionsThe institutional policy changes have led to lower rates of EHIT, with a reduction in severe EHIT rates in patients with an ≥8-mm diameter GSV or a ≥10-mm diameter SFJ treated with RFA. Of the changes implemented, restricting treatment to one vein was associated with a reduction in severe EHIT. No association was found with periprocedural low-molecular-weight heparin, although a type 2 error might have occurred. Alternative strategies to prevent thrombotic complications should be explored, such as increasing the dosage and duration of periprocedural anticoagulation, antiplatelet use, and nonpharmacologic strategies.

Strategy to optimize PeriproCeduraL AnticOagulation in structural transseptal interventions: Design and rationale of the STOP CLOT trial

Both transcatheter edge-to-edge repair (TEER) of mitral regurgitation or left atrial appendage closure (LAAC) require periprocedural anticoagulation with unfractionated heparin (UFH) that is administered either before or immediately after transseptal puncture (TSP). The optimal timing of UFH administration (before or after TSP) is unknown. The Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions trial (STOP CLOT Trial) was designed to determine if early anticoagulation is effective in reducing ischemic complications without increasing the risk of periprocedural bleeding.The STOP CLOT trial is a multicenter, prospective, double-blind, placebo-controlled, randomized trial. A total of 410 patients scheduled for TEER or LAAC will be randomized 1:1 either early UFH administration (iv. bolus of 100Units/kg UFH or placebo, given after obtaining femoral vein access and at least 5 minutes prior to the start of the TSP) or late UFH administration (iv. bolus of 100Units/kg UFH or placebo given immediately after TSP). Prespecified preliminary statistical analysis will be performed after complete follow-up of the first 196 randomized subjects. To ensure blinding, a study nurse responsible for randomization and UFH/placebo preparation is not involved in the care of the patients enrolled into the study. The primary study endpoint is a composite of (1) major adverse cardiac and cerebrovascular events (death, stroke, TIA, myocardial infarction, or peripheral embolization) within 30 days post-procedure, (2) intraprocedural fresh thrombus formation in the right or left atrium as assessed with periprocedural transesophageal echocardiography, or (3) occurrence of new ischemic lesions (diameter ≥4 mm) on brain magnetic resonance imaging performed 2-5 days after the procedure. The safety endpoint is the occurrence of moderate or severe bleeding complications during the index hospitalization. Protocols of periprocedural anticoagulation administration during structural interventions have never been tested in a randomized clinical trial. The Stop Clot trial may help reach consensus on the optimal timing of initiation of periprocedural anticoagulation.

Abstract WP98: Variability of Perioperative Anticoagulation Strategies in Patients With Atrial Fibrillation

Introduction: In patients with atrial fibrillation (AFib) whose anticoagulation (AC) requires being held prior to non-emergent surgery, ischemic stroke is an unfortunately familiar event. Current practices in the holding of anticoagulation pre-op and the use of bridging therapy are heterogeneous, the guidelines for which are often underutilized. Methodology: We surveyed cardiologists, general practitioners and surgical specialists across a single large academic-based healthcare institution regarding periprocedural AC practices in patients with AFib. Data were organized by provider type and experience. Chi-square, Fisher exact, and Student's t-tests were used to analyze differences in anticoagulation practices. Results: Of 2,604 surveys emailed, 14 cardiologist, 53 general practitioners and 70 procedural/surgical specialists participated. Average number of days surgical specialists required holding AC were 2.6 (SD = 1.2) for direct oral anticoagulant (DOAC) and 4.6 (SD=1.6) for warfarin. INR goal averaged 1.6 (SD 0.3). Surgical specialists required bridging therapy for DOAC significantly less often than they did for warfarin, 15.5% vs 44.3%, X 2 = 14.0, p &lt; 0.001. Timing of DOAC held and warfarin held did not differ between attendings and trainees, nor did threshold goal INR. In contrast, practices between non-surgical specialists widely differed. Cardiologists trended roughly 4 times less likely than general practitioners to prescribe bridging therapy while DOAC was held, X 2 = 3.3, p = 0.06, yet they also trended toward prescribing bridging therapy more often for patients who had history of ischemic stroke. Significantly, attendings were 5 times less likely than residents to prescribe bridging therapy for DOACs and 3x times less likely to do so for warfarin, X 2 = 14.9, p = 0.0001 and X 2 = 5.5, p = 0.01, respectively. Conclusion: Our data indicate that significant differences exist in pre-op anticoagulation recommendations across provider type as well as training level. These differences are most stark in the use of bridging therapy while anticoagulation is held. Surgeons demonstrated more consistency in their anticoagulation strategies than did non-surgical providers.

Renal function and periprocedural complications in patients undergoing left atrial catheter ablation: A comparison between uninterrupted direct oral anticoagulants and phenprocoumon administration.

Data regarding uninterrupted oral anticoagulation in patients with chronic kidney disease (CKD) during catheter ablation for left atrial arrhythmias is limited. This study aimed to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulants (DOAC) compared with uninterrupted phenprocoumon in patients with CKD undergoing left atrial catheter ablation. We conducted a retrospective single-center study of patients who underwent left atrial catheter ablation between 2016 and 2019 with underlying chronic kidney disease (glomerular filtration rate (GFR) between 15 and 45ml/min). The primary objective of this study was to investigate whether direct oral anticoagulant (DOAC) therapy or warfarin presents a superior safety profile in patients with chronic kidney disease (CKD) undergoing left atrial catheter ablation. We compared periprocedural complications (arteriovenous fistula, aneurysm, significant hematoma (> 5cm)) and/or bleeding (drop in hemoglobin of >2g/dl, pericardial effusion, retroperitoneal bleeding, other bleeding, stroke) between patients receiving either uninterrupted DOAC or warfarin therapy. Secondary analysis included patient baseline characteristics as well as procedural data. A total of 188 patients (female n = 108 (57%), mean age 75.3 ± 8.1years, mean GFR 36.8 ± 6ml/min) were included in this study. Underlying arrhythmias were atrial fibrillation (n = 104, 55.3%) and atypical atrial flutter (n = 84, 44.7%). Of these, n = 132 patients (70%) were under a DOAC medication, and n = 56 (30%) were under phenprocoumon. Major groin complications including pseudoaneurysm and/or AV fistula occurred in 8.9% of patients in the phenprocoumon group vs. 11.3% of patients in the DOAC group, which was not statistically significant (p = 0.62). Incidence of cardiac tamponade (2.3% vs. 0%; p = 0.55) and stroke (0% vs. 0%) were low in both DOAC and phenprocoumon groups with similar post-procedural drops in hemoglobin levels (1.1±1g/dl vs 1.1±0.9g/dl; p= 0.71). The type of anticoagulation had no significant influence on bleeding or thromboembolic events as well as groin complications in this retrospective study. Despite observing an increased rate of groin complications, the uninterrupted use of DOAC or phenprocoumon during left atrial catheter ablation in patients with CKD appears to be feasible and effective.

One-Day Interruption of NOAC Is Associated with Low Risk of Periprocedural Adverse Events during Pulmonary Vein Isolation If Combined with Left Atrial Thrombus Exclusion with Computed Tomography.

Safety, efficacy, and patient comfort are the expectations during pulmonary vein isolation (PVI). We aimed to validate the combined advantages of pre- and periprocedural anticoagulation with non-vitamin K anticoagulants (NOACs) and rigorous left atrial appendage thrombus (LAAT) exclusion with computed tomography (CT). This study included a population of consecutive patients, between March 2018 and June 2020, who underwent cardiac CT within 24 h before PVI to guide the ablation and rule out LAAT. NOAC was omitted 24 h before the ablation. A total of 187 patients (63% male) underwent CT before PVI. None of the patients experienced stroke during or after the procedure. The complication rate was low, with no thromboembolic events and 2.1% of patients experiencing a major bleeding event. Omitting NOAC 24 h before the ablation might be safe if combined with left atrial thrombus exclusion with computed tomography.

Periprocedural management of direct oral anticoagulants in patients with atrial fibrillation and active cancer

BackgroundCancer and atrial fibrillation (AF) are common concurrent disorders. Direct oral anticoagulants (DOACs) are prescribed to prevent stroke in patients with AF. Patients with cancer often undergo invasive procedures for diagnostic or therapeutic purposes, necessitating interruption of anticoagulation. There are limited data to guide best periprocedural anticoagulation management practices in the setting of active cancer. ObjectivesTo describe patient characteristics, periprocedural management, and clinical outcomes in DOAC-treated patients with AF according to active cancer status. MethodsWe conducted descriptive and comparative analyses using data from the PAUSE study. Multivariable logistic regression was used to determine whether active cancer status was an independent risk factor for bleeding outcomes. Covariates were selected a priori based on biological rationale and preexisting knowledge. ResultsPatients with active cancer were older (P < .001), more likely to be thrombocytopenic (P = .026), have moderate renal dysfunction (P = .005), and more likely to receive low-dose DOAC therapy (P < .001). A greater proportion of patients with active cancer underwent a high-bleed-risk procedure (P < .001), with longer periprocedural DOAC-interruption intervals (P <.001) and lower preprocedural residual DOAC levels (P = .002). Active cancer was an independent predictor for surgical major bleeding (OR = 2.45; 95% CI, 1.08-5.14) after adjusting for study center, procedure category and bleed risk, thrombocytopenia, hypertension, and the use of a P2Y12 inhibitor. ConclusionsActive cancer status is associated with an increased risk of surgical major bleeding among DOAC-treated patients with AF undergoing interruption of anticoagulation for elective invasive procedures.

Abstract 15203: Periprocedural Oral Anticoagulation for Ventricular Tachycardia Ablation and Postprocedural Stroke - Analysis of a Japanese Nationwide Inpatient Database

Introduction: The effectiveness and the safety of periprocedural anticoagulation for ventricular tachycardia (VT) ablation remain to be clarified. Hypothesis: Periprocedural anticoagulation reduces the incidence of ischemic stroke after VT ablation without increasing intracranial hemorrhage. Methods: Using the Japanese Diagnosis Procedure Combination database, we identified patients aged ≥18 years who underwent VT ablation from July 2010 to March 2021. The endpoints were ischemic stroke and intracranial hemorrhage which occurred during the hospitalization of the index VT ablation or led to re-admissions within three months. We performed weighted analyses using inverse probability of treatment based on propensity-score to adjust for confounding factors. We also conducted analyses stratified by antiplatelet use. Results: We identified 18,894 patients from 750 hospitals who underwent VT ablation (12,918 males [68%], 60.5 ± 15.7 years). Postprocedural ischemic stroke and intracranial hemorrhage were documented in 84 (0.44%) and 15 (0.08%) cases, respectively. Anticoagulants and antiplatelets were administered in 4352 (23.0%) and 5319 (28.2%) patients, respectively. Propensity score-weighted analysis demonstrated no significant association between anticoagulant use and postprocedural ischemic stroke (odds ratio, 0.91; 95% confidence interval [CI], 0.51-1.63; P=0.76). Anticoagulation was also not associated with intracranial hemorrhage (odds ratio, 2.15; 95% CI, 0.65-7.15; P=0.21). In the stratified analysis, anticoagulation was associated with an increased risk of intracranial hemorrhage in patients with antiplatelets (odds ratio, 6.30; 95% CI, 1.26-31.5; P=0.025) but not in those without. Conclusions: Our analysis of Japanese patients who underwent VT ablation suggests that periprocedural administration of anticoagulants may not result in a reduction of ischemic strokes and that adding anticoagulants to antiplatelet therapy may increase the risk of intracranial hemorrhage. Further studies are warranted to investigate the clinical efficacy of periprocedural anticoagulation strategy after VT ablation.

Standardizing periprocedural anticoagulation management: a stewardship initiative.

Study data indicates anticoagulant interruption peri-procedurally can increase the risk of anticoagulation-related bleeding and thrombosis. Management of anticoagulated patients during the peri-procedural period poses clinical challenges given the potential for thrombosis and bleeding in this complex, high risk population. As such, there is a need for enhanced emphasis on anticoagulated patient care throughout the peri-procedural period with the goal of optimizing patient safety and efficacy. To operationalize an effective, efficient, comprehensive, and standardized anticoagulation management peri-procedural process housed within the electronic health record (EHR). The IPRO-MAPPP clinical decision support logic was adapted into a nurse-managed protocol to guide anticoagulation therapy use during the elective peri-procedural period at Bassett Medical Center, an Anticoagulation Forum Center of Excellence. A second phase of this initiative endorsed peri-procedural warfarin and bridging management by the Anticoagulation Management Service. Outcomes revealed 30-day hospital or emergency department admissions remained at or below 1% of the surgical patient population, and below the published national standards for both phases of implementation. Further, no emergent anticoagulation reversal agent use was attributed to peri-procedural care during the assessment period. The phased implementation of this Anticoagulation Stewardship initiative in elective peri-procedural anticoagulation management successfully describes the operationalization and demonstration of high-quality care and low provider practice variation from policy. The integration of clinical decision support systems, in consort with effective communication, via the EHR, provides stability, sustainability, and drives high quality care to optimize patient outcomes.

Safety of epinephrine-containing local anaesthesia in CIED implantations

Abstract Funding Acknowledgements Type of funding sources: None. Background Cardiac implantable electronic devices (CIED) are common. Permanent pacemaker implantations can improve quality of life of patients with sick-sinus syndrome and prolong survival in those with infranodal high-grade AV block. Nonetheless, pocket haemathoma can be problematic post CIED implantation, especially with the increasing use of oral anticoagulants and antiplatelet agents (especially P2Y12 inhibitors) in the at-risk population. The use of epinephrine in local anaesthetic is common in UK but remains controvesial with 2021 EHRA consensus statement recommending its avoidance(1). Aim To compare the rate of pocket haemathoma and subsequent haemathoma drainage and pocket revisions in CIED patients who have received epinephrine-containing local anaesthetia versus local anesthesia without epinephrine. Methods Retrospective, observational studies across a disctrict general hospital and tertiary cardiology hospital, involving a total of 377 consecutive CIED patients over the course of 2021 - 2022. Patients' demographics, comorbidities, peri-procedural medication use and complication events were retrived from electronic data base. Types of local anaesthesia were recorded. Results and Outcomes Out of 377 patients, 184 patients received 1% epinephrine-containing local anaesthesia (Group 1) and 193 patients received plain local anesthesia only (Group 2). In terms of baseline demographics (age and gender distribution), associated comorbidities (treated hypertension, diabetes type 2, ischaemic heart disease, hypercholesterolemia, smoker) were not statistically different between both groups. Number of leads implanted (DDD vs VVI vs ILR) were not statistically different (26.6% DDD pacemaker and 65.8% VVI pacemaker in Group 1 versus 34.8% DDD and 57.0% VVI in Group 2, p=0.143). Periprocedural usage of oral anticoagulations (38.6% vs 30.5%,p=0.102) and single or dual antiplatelet agents (31.5% vs 29.0%, p=0.796) were not different between both groups. Overall complication rates were low and not statistically different between both groups: 4.35% in Group 1 versus 6.74% in Group2. Only 1 patient received epinephine-containing local anesthesia experienced pocket haemathoma against 6 patients who received plain local anaesthsia (0.543% vs 3.11%,p=0.122). No patients require evacuation of haemathoma, drainage or subsequent pocket revision (p= 1.0). Summary: The results of this retrospective observational study demonstrated that 1% epinephrine-containing local anesthesia for CIED implantation is not associated with increased risk of pocket haemathoma, no increased risk of haemathoma evacuation, drainage or pocket revision. This is despite peri-procedural anticoagulation or antiplatelet use exceeding 70%. This "real-life" result is incongruent with the published MAITRE study which formed the basis for the 2021 EHRA expert consensus statement. Recommendation surrounding epinephrine-containing local anaesthesia in CIED implantation may need to be reviewed.

How to initiate aspirational embolectomy program for pulmonary embolism: single centre initial experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Recent advances in percutaneous mechanical thrombectomy provide lytic-free methods for treatment of pulmonary embolism (PE). Although guidelines recommend aspirational embolectomy only for high-risk PE patients with contraindication to or failed fibrinolysis, the method is currently being used in treatment of intermediate-high risk PE patients. We present our initial experiences with large bore percutaneous aspirational embolectomy catheter. Methods Patients with intermediate-high risk PE and at least one clinical feature (persistent hypoxemia, tachycardia, hypotension without shock, or dyspnoea on minimal exertion) were considered eligible for the method. Positive high-sensitive troponin was obligatory. PE was diagnosed by computed tomography. Echocardiography and doppler ultrasound of lower limbs venous system were performed upon admission. All procedures were performed by interventional cardiologist in cardiology suite. Light sedation with dexmedetomidine and/or midazolam was used. Ultrasound guided right or left femoral approach was used in all patients. A 7F balloon tipped catheter was used to cross the tricuspid and pulmonary valves and engage pulmonary artery (PA). After exchanging for 6F pigtail catheter an angiography was performed. Then, via multipurpose 6F catheter an extra-stiff wire was introduced distal to the thrombus. Over the wire a 20F or 24F aspirational embolectomy catheter was placed in front of the thrombus followed by the aspiration with 60 ml syringe. Up to 10 aspirations were allowed. Unfractionated heparin was used for periprocedural anticoagulation followed by apixaban or rivaroxaban as soon as hemostasis was achieved. Patients outcomes were recorded prospectively. Results From March to October 2022 a total of 10 patients were treated with aspirational embolectomy (6 females, median age 68.5 years (interquartile range 53.25-74)). Only the first case was performed with 20F catheter. In 9 patients sheathless approach was used due to material unavailability. In one case switching to left-side access was required due to inability to introduce the catheter in common femoral vein. In two cases a "lollipop" phenomenon occurred, one of which was a thrombus-in-transit (TIT) case. This case was complicated with TIT fragmentation on exit and re-embolism with circulatory arrest requiring veno-arterial extracorporeal circulatory support. Procedural success was achieved in all cases (in TIT patient two procedures were needed). All patients reported improvements in dyspnea levels. One patient required oxygen supplementation beyond 24h (TIT patient). Average PA systolic and diastolic blood pressure drop was 24.3±11.0 and 12.3±4.9 mmHg. Nine patients were alive at discharge, while TIT patient was still requiring hospitalisation. Conclusion Aspirational embolectomy can provide sufficient drop in PA pressures and symptom relief. Randomised trials are needed to determine the long term outcomes of the procedure.

Thromboembolic outcomes are decreased with the use of a standardized venous thromboembolism risk assessment and prophylaxis protocol for patients undergoing superficial venous procedures

ObjectivePatients with venous insufficiency can be treated with ablation or phlebectomy, or both. Patients undergoing superficial venous procedures have an elevated risk of deep vein thrombosis (DVT) and pulmonary embolism (PE). At our institution, we initiated a standardized protocol in which patients with a Caprini score (2005 version) of ≥8 are treated with 1 week of prophylactic anticoagulation after the procedure. Duplex ultrasound was performed at 1 week and then within 90 days after the procedure. This aim of the present study was to determine the thrombotic and clinical outcomes after superficial vein procedures using a standardized protocol for DVT/PE risk assessment and prophylaxis. MethodsWe performed a retrospective analysis of prospectively collected data of superficial vein procedures from 2015 to 2021 at a single center. The patient demographics, CEAP (Clinical-Etiology-Anatomy-Pathophysiology) clinical class, venous clinical severity score, patient-reported outcomes, treatment type, Caprini scores, pre- and postoperative anticoagulation use, and outcomes were collected. Descriptive statistics were used for the patient demographics, procedure details, and unadjusted surgical outcomes. Multivariable logistic regression was used to evaluate the relationship between procedure type and DVT and PE after adjusting for patient characteristics, disease severity, periprocedural anticoagulation, and Caprini score. ResultsA total of 1738 limbs were treated with ablation (n = 820), phlebectomy (n = 181), or ablation and phlebectomy (n = 737). More patients were women (67.1%) and White (90.9%). The overall incidence of DVT/PE was 1.4%. Patients undergoing ablation with phlebectomy had higher rates of DVT/PE (2.7%) than those undergoing ablation (0.2%) or phlebectomy alone (1.7%; P < .01). However, only 30% of DVTs were above the knee. On multivariate analysis, only the procedure type predicted for DVT/PE. However, patients undergoing ablation and phlebectomy achieved better patient-reported outcomes (Caprini score, 5.9) compared with those undergoing ablation (Caprini score, 7.2) or phlebectomy (Caprini score, 7.9) alone (P < .01). The best improvement in the venous clinical severity score was seen with phlebectomy alone. ConclusionsThe expected difference in the DVT/PE rates between high- and low-risk groups did not materialize in our patients, perhaps secondary to the additional chemoprophylaxis prescribed for the high-risk cohort (Caprini score, ≥8). These results call for a randomized trial to assess the efficacy of a standardized protocol in the reduction of DVT/PE after superficial vein procedures.

Role of catheter-directed therapies in the treatment of acute pulmonary embolism. Expert opinion of the Polish PERT Initiative, Working Group on Pulmonary Circulation, Association of Cardiovascular Interventions, and Association of Intensive Cardiac Care of the Polish Cardiac Society.

Thanks to advances in interventional cardiology technologies, catheter-directed treatment has become recently a viable therapeutic option in the treatment of patients with acute pulmonary embolism at high risk of early mortality. Current transcatheter techniques allow for local fibrinolysis or embolectomy with minimal risk of complications. Therefore, these procedures can be considered in high-risk patients as an alternative to surgical pulmonary embolectomy when systemic thrombolysis is contraindicated or ineffective. They are also considered in patients with intermediate-high-risk pulmonary embolism who do not improve or deteriorate clinically despite anticoagulation. The purpose of this article is to present the role of transcatheter techniques in the treatment of patients with acute pulmonary embolism. We describe current knowledge and expert opinions in this field. Interventional treatment is described in the broader context of patient care organization and therapeutic modalities. We present the organization and responsibilities of pulmonary embolism response team, role of pre-procedural imaging, periprocedural anticoagulation, patient selection, timing of intervention, and intensive care support. Currently available catheter-directed therapies are discussed in detail including standardized protocols and definitions of procedural success and failure. This expert opinion has been developed in collaboration with experts from various Polish scientific societies, which highlights the role of teamwork in caring for patients with acute pulmonary embolism.

Impact of coronary artery disease on clinical outcomes after TAVR: Insights from the BRAVO-3 randomized trial.

To determine the prognostic impact of coronary artery disease (CAD) in patients randomized to bivalirudin or unfractionated heparin (UFH) during transcatheter aortic valve replacement (TAVR). CAD is a common comorbidity amongpatients undergoing TAVR and studies provide conflicting data on its prognostic impact. The Bivalirudin on Aortic Valve Intervention Outcomes-3 (BRAVO-3) randomized trial compared the use of bivalirudin versus UFH in 802 high-surgical risk patients undergoing transfemoral TAVR for severe symptomatic aortic stenosis. Patients were stratified according to the presence or absence of history of CAD as well as periprocedural anticoagulation. The coprimary endpoints were net adverse cardiac events (NACE; a composite of all-cause mortality, myocardial infarction, stroke, or major bleeding) and major Bleeding Academic Research Consortium (BARC) bleeding ≥3b at 30 days postprocedure. Among 801 patients, 437 (54.6%) had history of CAD of whom 223 (51.0%) received bivalirudin. There were no significant differences in NACE (adjusted odds ratio [OR]: 1.04; 95% confidence interval [CI]: 0.69-1.58) or BARC ≥ 3b bleeding (adjusted OR: 0.84; 95% CI: 0.51-1.39) in patients with vs without CAD at 30 days. Among CAD patients, periprocedural use of bivalirudin was associated with similar NACE (OR: 0.80; 95% CI: 0.47-1.35) and BARC ≥ 3b bleeding (OR: 0.64; 95% CI: 0.33-1.25) compared with UFH, irrespective of history of CAD (p-interaction = 0.959 for NACE; p-interaction = 0.479 for major bleeding). CAD was not associated with a higher short-term risk of NACE or major bleeding after TAVR. Periprocedural anticoagulation with bivalirudin did not show any advantage over UFH in patients with and without CAD.

Periprocedural Anticoagulation.

Management of patients taking anticoagulants around the time of a procedure is a common and complex clinical scenario. Providing evidence-based care requires estimation of risk for thrombosis and bleeding, knowledge of commonly used medications, multidisciplinary communication and collaboration, and patient engagement and education. This review provides a standardized, evidence-based approach to periprocedural management of anticoagulation, based on current evidence and expert clinical guidelines.

Real-world comparison of in-hospital complications after catheter ablation for atrial fibrillation between non-antivitamin K anticoagulants and warfarin: A propensity-matched analysis using nation-wide database.

Few large-scale, real-world studies have compared the efficacy and safety of non-antivitamin K anticoagulants (NOACs) with that of warfarin in catheter ablation (CA) for atrial fibrillation (AF). This retrospective, cross-sectional study used a nationwide administrative claims database, to compare complication-incidence rates following CA for AF between NOAC-treated patients and warfarin-treated matched cohorts in the real-world. Among the 32,797,540 records between June 2011 and August 2020 from 426 hospitals, 41,347 patients (38,065 on NOACs and 3,282 on Warfarin) were considered eligible. After performing propensity matching, 6,564 patients (3,282 per group) were analyzed. The overall complication incidence was significantly lower in the NOACs group than in the warfarin group(2.3% vs. 4.0%; P<0.001, odds ratio [OR]: 0.55, 95% confidence interval [CI]: 0.41-0.74). Although no significant differences in the incidence of cardiac tamponade (1.0% vs. 1.1%; P=0.90, OR: 0.97, 95% CI: 0.60-1.56) and major bleeding (0.6% vs. 0.7%; P=0.54, OR: 0.83, 95% CI: 0.44-1.52) were noted, blood transfusion requirements (0.6% vs. 1.2%; P=0.02, OR: 0.52, 95% CI: 0.30-0.88) and vascular complications (0.2% vs. 0.5%; P=0.02, OR: 0.33, 95% CI: 0.12-0.79) were significantly lower in the NOACs group than in the warfarin group. Furthermore, the thromboembolic event incidence was significantly lower in the NOACs group than in the warfarin group (0.5% vs. 1.2%; P<0.001, OR: 0.36, 95% CI: 0.19-0.64). NOACs should be considered as a first-line therapy for periprocedural anticoagulation in patients undergoing CA for AF.