Uninterrupted Oral Anticoagulation Research Articles

Objective randomised blinded investigation of therapeutic ablation versus cardioversion for persistent atrial fibrillation- outcomes of the feasibility

Abstract Background Patients with persistent atrial fibrillation (pers.AF) commonly undergo catheter ablation (CA) for symptom relief and improved quality of life(QoL). However,the benefits of CA compared to DC cardioversion (DCCV) or medical therapy lack substantial evidence from blinded randomized trials. Purpose Conducting such a large-scale trial presents substantial challenges in terms of recruitment, maintaining blinding, and implementation.To address this, we conducted a pilot study prior to a definitive larger study. Methods This feasibility trial is a single-centre, prospective, randomised, double-blinded placebo control study. Patients with early pers AF (<2 years) eligible for pulmonary vein isolation (PVI) or DCCV were enrolled. Twenty patients were recruited, accounting for 10% of the proposed larger trial based on power calculation. The intervention arm (PVI + DCCV) and placebo arm (Placebo + DCCV) were randomised in a 1:1 manner after ultrasound-guided vascular access with local anaesthetic and deep sedation (Midazolam + opioid). All procedures were performed as day cases on uninterrupted oral anticoagulation. Phrenic nerve pacing was performed in the Placebo group, mimicking lab interactions and fluoroscopy system movements. Implantable loop monitors were inserted immediately after heparin reversal and groin sheath removal. A 6-week(wk) blanking period was observed post-procedure. Blinding was assessed using Bang's blinding index (BI) for both patients and medical staff and a successful blinding is considered BI between -0.2 to 0.2. Health-related quality of life (HRQoL) was evaluated using SF12, EQ5D-5L, and AF PROMS. The study obtained ethical approval (REC ref 19/LO/0775),adhered to the principles of the Declaration of Helsinki,and obtained written informed consent from all participants. Results A remarkable 92% of patients approached, expressed a willingness to participate in the study. Procedure time and time to discharge were similar between groups. The study successfully achieved blinding among the patients at day0 (BI = PVI-0.2 vs placebo- 0) and was maintained throughout the 6-wk and 3M follow-up, among the patients as well as clinical staff. HRQoL improved in the active group in terms of AF PROMS [Improved difference from baseline PVI 23 (±22); vs Placebo 2 (±10), p=<0.001 and SF-12 mental component (MCS) at 12M (PVI 11.8 (±11) vs placebo 8.54(±11.5), p= 0.017). Over a follow up period of 12M, there was a trend towards greater recurrence (60% vs 30%; p=0.07) and repeat procedures (70% vs 40%; p=0.4) in the placebo group. Conclusion: Performing a blinded placebo-controlled interventional study to assess the efficacy of PVI is feasible and high recruitment rates are achievable. CA appears to result in better arrhythmic and QoL outcomes;a full-scale follow-on study will assess the true efficacy of CA in patients with early pers.AF and allow consideration of whether there is a role for DCCV in many patients.

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.

Safety and Efficacy of Uninterrupted Oral Anticoagulation in Patients Undergoing Catheter Ablation for Atrial Fibrillation with Different Techniques.

The safety and efficacy of an uninterrupted direct anticoagulation (DOAC) strategy during catheter ablation (CA) for atrial fibrillation (AF) has not been fully investigated with different ablation techniques. We evaluated consecutive AF patients undergoing catheter ablation with three different techniques. All patients were managed with an uninterrupted DOAC strategy. The primary endpoint was the rate of periprocedural thromboembolic and bleeding events. The secondary endpoints of the study were the rate of MACE and bleeding events at one-year follow-up. In total, 162 patients were enrolled. Overall, 53 were female and the median age was 60 [55.5-69.5] years. The median CHA2DS2-VASc and HAS-BLED scores were 2 [1-4] and 2 [1-2], respectively. In total, 16 patients had a past stroke or TIA while 11 had a predisposition or a history of bleeding. The CA procedure was performed with different techniques: RF 43%, cryoballoon 37%, or laser-balloon 20%. Overall, 35.8% were on rivaroxaban, 20.4% were on edoxaban, 6.8% were on apixaban, and 3.7% were on dabigatran. All other patients were all naïve to DOACs; the first anticoagulant dose was given before the ablation procedure. As for periprocedural complications, we found three groin hematomas not requiring interventions, one ischemic stroke, and one systemic air embolism (the last two likely due to several catheter changes through the transeptal sheath). Five patients reached the secondary endpoints: one patient for a myocardial infarction while four patients experienced minor bleeding during 1-year follow-up. Our results corroborate the safety and the efficacy of uninterrupted DOAC strategy in patients undergoing CA for AF, regardless of the ablation technique.

Subxiphoid epicardial access facilitated by saline infusion or carbon dioxide insufflation through a right atrial appendage controlled exit

Abstract Funding Acknowledgements Type of funding sources: None. Background Subxiphoid percutaneous access to the pericardial space for mapping and ablation of atrial and ventricular arrhythmia carries the potential risk of cardiac perforation and coronary artery laceration. Widening the pericardial space with saline solution or carbon dioxide (CO2) insufflation by intentional coronary vein exit prior to subxiphoid puncture reduces the risk of organ lesion. However, cannulation of a coronary branch is often difficult and adds complexity to the ablation procedure. Purpose To determine the feasibility and the safety of subxiphoid epicardial access facilitated by controlled pericardial saline infusion or neumopericardium through a right atrial appendage exit. Methods The right atrial appendage was transvenously cannulated using a steerable sheath following anatomical characterization of the right atrium on an electroanatomical navigation system. A 0.014" angioplasty guide was introduced with the proximal rigid end placed distally and progressed until the appendage was perforated and the guide-wire placed into the pericardial space. A double lumen microcatheter was then progressed over the wire. Saline solution (100-400 mL) or CO2 (100-500 cc) were infused through the microcatheter to achieve sufficient pericardial space widening or hemodynamic deterioration. Finally, pericardial access was obtained using the conventional subxiphoid approach. Results 17 consecutive patients (62±10 years, 15 male) with left atrial flutter (LAF n=11) or ventricular tachycardia (VT n=6) refractory to endocardial ablation were prospectively included. All patients with atrial flutter (uninterrupted oral anticoagulation plus heparin for ACT >300 sec) and ventricular tachycardia (heparin for ACT >300 sec) were fully anticoagulated at the time of the procedure. It was not possible to access epicardium in 4 patients due to adhesions (VT=3 LFA=1). The first 4 patients with successful access had saline infused and the remaining 9 patients had CO2 insufflated. Epicardial tachycardia ablation was successfully achieved in 8 patients (5 AFLs and 3 VTs) and partially successful in 1 patient (1AFL). A pericardial drainage was left in 6 patients before leaving the EP laboratory and removed in the remaining. There was no apparent right ventricular puncture, coronary artery laceration or other major complications. One patient had cardiac tamponade during the procedure and 2 other patients presented tamponade after the procedure following discharge from the interventional lab. One patient presented neumomediastinum and other patient presented subcutaneous emphysema, which resolved uneventful in 24 hours. Conclusions Saline infusion or carbon dioxide insufflation through a right atrial appendage controlled exit facilitates subxiphoid epicardial access for ablation of refractory atrial and ventricular arrhythmias. This approach can be performed in the majority the patients and appears to be safe.

Cerebral microembolic signal burden during pulsed field ablation: preliminary results from robotically-assisted transcranial doppler and magnetic resonance imaging

Abstract Funding Acknowledgements Type of funding sources: None. Background Transcranial Doppler (TCD) has been used to monitor the burden of cerebral microembolic signals (MESs) during atrial fibrillation (AF) ablation. MES burden is considered a surrogate marker for stroke risk and has never been reported during AF ablation with pulsed field ablation (PFA). Purpose To assess the MES burden during AF ablation with point-by-point radiofrequency (RF) versus single-shot PFA. Methods Fifteen consecutive paroxysmal and persistent AF patients underwent catheter ablation via either single-shot (2000V) PFA [n=7, median age: 56yo (range:53-73), 85.7% males] or point-by point (45W) RF [n=8, median age: 58yo (range 56-74), 62.6% males] under uninterrupted oral anticoagulation and a periprocedural ACT≥300s. Peri-procedural TCD was performed via a robotically-assisted ultrasound system, which includes an Artificial Intelligence-powered robotic headset designed to automate signal acquisition and reduce interoperator variability of TCD findings (Figure 1). Ablation-related asymptomatic cerebral embolism (CE) was assessed via diffusion-weighted imaging (DWI) sequences at magnetic resonance imaging (MRI) performed 24-48h post-ablation. Results Among the 7 PFA patients, the median number of applications to achieve PV isolation was 35 (range:33-42). Five (71.4%) patients showed multiple MESs clustered in a shower-like pattern (Figure 2). The overall number of MES-showers was 51 [median: 9 (range:8-15)] and they were temporally correlated with a PFA application. Shower formation was more common after a PFA application to the right superior pulmonary vein [(PV); 19 cases (37.3%)], followed by the right inferior PV [16 cases (31.4%)], the left inferior PV [14 cases (27.5%)], and the left superior PV [2 cases (3.9%)]. A single shower-like pattern was documented among the 8 RF patients, following a stem-pop while ablating at the right inferior PV antrum. There were no procedure-related complications and none of the 15 patients showed any post-ablation neurological symptoms. The mean time from ablation to MRI was 29±4hours; DWI imaging revealed no acute cerebral microembolic lesions. Conclusion PFA generated a relevant number of MESs frequently clustered in short-lasting shower-like patterns. The composition of MESs, their exact mechanism of formation, and the impact on neurological outcomes are unknown and will be addressed in future studies.

Percutaneous management of atrial wall perforation during transeptal puncture with an Amplatzer vascular plug in 3 patients: keep calm, think fast

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Atrial wall perforation is a rare but serious complication of transeptal puncture in AF catheter ablation procedure. In patients with uninterrupted anticoagulation associated to non-fractionated heparin bolus this may lead to cardiac tamponade and dramatic consequences. Urgent surgical drainage and repair is mandatory in the most dramatic cases. We report the successful closure of such complication by an Amplatzer vascular plug leading to a rapid and total recovery in 3 patients. Methods Three patients (male, 43, 77 and 84 yo) referred for persistent atrial fibrillation ablation (1 RF and 2 cryoablations). After transeptal puncture, they became severely hypotensive with echographic evidence of tamponade. Results Heart perforation with massive leakage of contrast in the pericardial space was evident. The perforation was anterior near aorta in one, on the posterior wall of the right atrium in one and on the posterior wall of the left atria though the right atria in one. After heparin antagonization by protamin, the pericardial space was drained percutaneously (1 to 3 l drained and in 1 reinjected through a "cell saver" system). Rapidly, a 0,035 J guide wire was passed through the perforation and an Amplatzer vascular Plug 2 (4 mm in 2 patients and 6 mm in one) was released resulting in an immediate closure of the leak and recovery of the patient after completion of the pericardial drainage. The drainage was monitored 24h and patients were discharged on Day 2 with a good evolution over a median follow-up of 1.5 year. CT scan at 3 and 6 month showed total recovery. Conclusion In patients with left atrial wall perforation and tamponade related to failed transeptal puncture in patients under uninterrupted oral anticoagulation for AF ablation, rapid release of a closure device and pericardial evacuation allowed to successfully manage the cardiac tamponade and avoid a surgical option.

Antithrombotic management in patients undergoing cardiac implantable electronic device implantation

Cardiac implantable electronic devices (CIEDs) are an established treatment option for arrhythmias, sudden cardiac death prevention, and heart failure. Approximately 1000 devices are implanted per million inhabitants in European countries each year. However, the main concern in patients with an indication for CIED implantation is frequently associated with comorbidities requiring antithrombotic medications. The invasive device implantation procedure represents a bleeding risk ranging from pocket hematoma to cardiac tamponade. On the other hand, temporary interruption of antithrombotic therapy increases the risk for thromboembolic events. Implanting CIEDs in patients on antithrombotic medications incites several clinical dilemmas of balancing thromboembolic risk against bleeding risk, as complications are associated with higher mortality rates in both aspects. The most common bleeding complication is pocket haematoma formation, which is associated with a prolonged hospital stay, higher cost, higher risk of pocket infection, and thus higher morbidity and mortality. Studies have shown that the heparin bridging strategy in patients on oral anticoagulants imposes a greater risk for pocket haematoma formation and no benefit in reducing thromboembolic events. Most procedures of CIED implantation can be performed safely with uninterrupted oral anticoagulants. Dual antiplatelet therapy increases the risk of pocket haematoma and should be avoided whenever possible.

Feasibility and clinical benefits of the double-ProGlide technique for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants.

To access the efficacy and safety of the double-ProGlide technique for the femoral vein access-site closure in cryoballoon ablation with uninterrupted oral anticoagulants (OAC), and its impact on the electrophysiology laboratory time as well as hospital stay after the procedure in this observational study. Patients with atrial fibrillation undergoing cryoballoon ablation with uninterrupted OAC at Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China from May 2019 to May 2021 were enrolled in this study. From October 2020, double-ProGlide technique was consistently used for hemostasis (ProGlide group), and before that conventional manual compression was utilized (manual compression group). The occurrence of vascular and groin complications was accessed during the hospital stay and until the three-month follow-up. A total of 140 participants (69.30% of male, mean age: 59.21 ± 10.29 years) were evaluated, 70 participants being in each group. Immediate hemostasis was achieved in all the patients with ProGlide closure. No major vascular complications were found in the ProGlide group while two major vascular complications were occurred in the manual compression group. The incidence of any groin complication was obviously higher in subjects with manual compression than patients with ProGlide devices (15.71% vs. 2.86%, P = 0.009). In addition, compared with the manual compression group, the ProGlide group was associated with significantly shorter total time in the electrophysiology laboratory [112.0 (93.3-128.8) min vs. 123.5 (107.3-158.3) min, P = 0.006], time from sheath removal until venous site hemostasis [3.8 (3.4-4.2) min vs. 8.0 (7.6-8.5) min, P < 0.001], bed rest time [8.0 (7.6-8.0) h vs. 14.1 (12.0-17.6) h, P < 0.001] and hospital stay after the procedure [13.8 (12.5-17.8) h vs. 38.0 (21.5-41.0) h, P < 0.001]. Utilization of the double-ProGlide technique for hemostasis after cryoballoon ablation with uninterrupted OAC is feasible and safe, which has the clinical benefit in reducing the total electrophysiology laboratory time and the hospital stay length after the procedure.

Multicenter experience with andexanet alfa for refractory pericardial bleeding during catheter ablation of atrial fibrillation.

Pericardial bleeding is a rare but life-threatening complication of atrial fibrillation (AF) ablation. Patients taking uninterrupted oral anticoagulation (AC) may be at increased risk for refractory bleeding despite pericardiocentesis and administration of protamine. In such cases, andexanet alfa can be given to reverse rivaroxaban or apixaban. In this study, we aim to describe the rate of acute hemostasis and thromboembolic complications with andexanet for refractory pericardial bleeding during AF ablation. In this multicenter, case series, participating centers identified patients who received a dose of apixaban or rivaroxaban within 24 h of AF ablation, developed refractory pericardial bleeding during the procedure despite pericardiocentesis and administration of protamine and received andexanet. Eleven patients met inclusion criteria, with mean age of 73.5 ± 5.3 years and median CHA2 DS2 -VASc score 4 [3-5]. All patients received protamine and pericardiocentesis, and 9 (82%) received blood products. All patients received a bolus of andexanet followed, in all but one, by a 2-hinfusion. Acute hemostasis was achieved in eight patients (73%) while three required emergent surgery. One patient (9%) experienced acute ST-elevation myocardial infarction after receiving andexanet. Therapeutic AC was restarted after a mean of 2.2 ± 1.9 days and oral AC was restarted after a mean of 2.9 ± 1.6 days, with no recurrent bleeding. In patients on uninterrupted apixaban or rivaroxaban, who develop refractory pericardial bleeding during AF ablation, andexanet can achieve hemostasis thereby avoiding the need for emergent surgery. However, there is a risk of thromboembolism following administration.

Ultrasound-Guided Access Reduces Vascular Complications in Patients Undergoing Catheter Ablation for Cardiac Arrhythmias.

Femoral vascular access using the standard anatomic landmark-guided method is often limited by peripheral artery disease and obesity. We investigated the effect of ultrasound-guided vascular puncture (UGVP) on the rate of vascular complications in patients undergoing catheter ablation for atrial or ventricular arrhythmias. The data of 479 patients (59% male, mean age 68 years ± 11 years) undergoing catheter ablation for left atrial (n = 426; 89%), right atrial (n = 28; 6%) or ventricular arrhythmias (n = 28; 6%) were analyzed. All patients were on uninterrupted oral anticoagulants and heparin was administered intravenously during the procedure. Femoral access complications were compared between patients undergoing UGVP (n = 320; 67%) and patients undergoing a conventional approach (n = 159; 33%). Complication rates were also compared between patients with a BMI of &gt;30 kg/m2 (n = 136) and patients with a BMI &lt; 30 kg/m2 (n = 343). Total vascular access complications including mild hematomas were n = 37 (7.7%). In the conventional group n = 17 (10.7%) and in the ultrasound (US) group n = 20 (6.3%) total vascular access complications occurred (OR 0.557, 95% CI 0.283-1.096). UGVP significantly reduced the risk of hematoma &gt; 5 cm (OR 0.382, 95% CI 0.148, 0.988) or pseudoaneurysm (OR 0.160, 95% CI 0.032, 0.804). There was no significant difference between the groups regarding retroperitoneal hematomas or AV fistulas (p &gt; 0.05). In patients with BMI &gt; 30 kg/m2, UGVP led to a highly relevant reduction in the risk of total vascular access complications (OR 0.138, 95% CI 0.027, 0.659), hematomas &gt; 5 cm (OR 0.051, 95% CI 0.000, 0.466) and pseudoaneurysms (OR 0.051, 95% CI 0.000, 0.466). UGVP significantly reduces vascular access complications. Patients with a BMI &gt; 30 kg/m2 seem to particularly profit from a UGVP approach.

Abstract 14704: Comparison of Anticoagulation Strategies for Epicardial Access in Ventricular Tachycardia Catheter Ablation

Introduction: Percutaneous epicardial access (EpiAcc) is frequently required for endo-epicardial ablation of ventricular tachycardia (VT), especially in ischemic cardiomyopathy, where it has been demonstrated to increase success rate. For patients who have indications for chronic oral anticoagulation (OAC), this often poses a challenge due to potential risks of procedural complications. We sought to assess the safety and outcomes of epicardial VT ablation on uninterrupted OAC compared to off anticoagulation. Methods: In this multicenter study, we retrospectively analyzed patients with ischemic cardiomyopathy and VT who underwent endo-epicardial ablation with EpiAcc. The study group included patients who underwent ablation either under uninterrupted OAC or off anticoagulation. Procedural data, outcomes, and complication rates were analyzed for comparison of both groups. Results: Overall, we analyzed 135 patients who underwent VT ablation via EpiAcc; 55 under full-dose uninterrupted AC and 80 off AC. There was no difference in procedure-related complications between both groups (1.8% vs 2.5%, p=0.09). There was no major bleeding requiring transfusion in any group. There was no difference in risk of cardiac tamponade between both groups (0% vs 0%, p=1). The rate of groin hematoma was 1.8% vs 1.3%, p=0.087). No thromboembolic events were reported. Conclusion: Epicardial VT ablation on uninterrupted OAC is a safe alternative to off AC, with no additional risk of life-threatening complications, thus preventing the possibility of thromboembolic events in patients who have an indication for chronic AC. 1

Coagulation Response and Prothrombotic Effect of Uninterrupted Oral Anticoagulant Administration AfterCatheter Ablation for VT.

Catheter ablation for ventricular tachycardia (VT) is associated with perioperative thromboembolic risk. However, the strategy for postprocedural management remains unknown. The aim of this study was to evaluate the prothrombotic response after VT ablation in various coagulation biomarkers in patients with and without the administration of oral anticoagulation (OAC). Data from 112 patients (58 with uninterrupted OAC and 54 without) with structural heart disease who underwent endocardial VT ablation were retrospectively analyzed. We also included 41 patients who underwent ablation for premature ventricular contraction from the right ventricle and 13 patients who underwent electrophysiology study (the control group). Blood samples of coagulation markers were collected before and 3days after the procedure in all patients. The percentage of D-dimer levels≤1.0μg/mL at baseline was lower in the VT ablation groups (76% and 50% in the OAC and non-OAC groups, respectively) than in the other groups (100%). After 3days, the percentage remained at 67% in the OAC group; however, the non-OAC VT group demonstrated a remarkable decrease of 20%. Similarly, fibrin monomer complex, thrombin antithrombin, and prothrombin fragment 1+2 levels were well suppressed in the control, premature ventricular contraction, and OAC groups. However, the non-OAC group demonstrated increased coagulation markers both before and after 3days. Multivariate analysis demonstrated that OAC administration and normal coagulation markers at baseline were independent predictors of stable coagulation status after ablation. The coagulation cascade was significantly activated in patients undergoing VT ablation. Uninterrupted OAC administration suppressed the coagulation response, which might be associated with a reduction in perioperative prothrombotic risk.

Early results of the novel radiofrequency balloon ablation catheter for pulmonary vein isolation

Abstract Funding Acknowledgements Type of funding sources: None. Background Pulmonary vein isolation (PVI) remains the cornerstone for treating of symptomatic atrial fibrillation (AF). Single-shot PVI technologies have evolved as a standard for first-time PVI. A novel radiofrequency balloon ablation catheter is now available to offer single-shot RF pulmonary vein isolation. Purpose To summarize the early experience using the novel RF balloon ablation catheter for patients undergoing PVI in two tertiary centres in Europe. Methods We prospectively assessed the first 38 consecutive patients undergoing PVI using RF balloon ablation catheter for paroxysmal or persistent AF in two high volume centres. Both centres used a standardised approach including ultrasound-guided vascular access, uninterrupted anticoagulation, transeptal puncture via the RF balloon sheath and a limited 3D mapping software-guided LA geometry created with a circular mapping catheter. Radiofrequency application for 60s to the anterior segments and 20s posteriorly was performed in all cases, phrenic pacing was employed for ablation of right PVs. BHS performed all procedures (except 2 cases due to high BMI and severe sleep apnea) under sedation, while all patients from UHZ underwent PVI procedures with general anaesthesia as per institutional protocol. All patients had an oesophageal temperature probe to assess oesophageal temperature during ablation (passed orally under sedation) and had uninterrupted oral anticoagulation throughout the periprocedural period. Results Overall, mean age was 64±8 years, 23 (61%) were male, 24 (63%) of patients had paroxysmal AF. The majority were de novo interventions (92%). There was no significant difference between the patients demographics in the two hospitals. All veins were isolated in both groups with a total of 144 applications (n = 73 in the sedation group, n = 71 in the GA population). Median fluoroscopy time was comparable (sedation group 1.1 minutes vs GA group 1.2 minutes; P = 0.58), but median procedure time was shorter in the sedation group (65 minute vs 106 minutes; P &amp;lt; 0.001). The median number of RF ablation per patient (sedation group 7 vs GA group 9; P = 0.32) and time to isolation of each vein (sedation group 11 seconds vs GA group 10 seconds; P = 0.9) were similar. Number of acute reconnections requiring further ablations were not significantly different between groups (sedation group 11 [15%] vs GA group 14 [20%]; P = 0.96). One patient sustained transient phrenic nerve injury in the sedation group. Conclusion Our early experience shows the novel HS balloon ablation can be performed effectively, efficiently and safely under either GA or conscious sedition. The RF balloon ablation catheter paradigm lends itself to refined workflows, with low fluoroscopy requirements and a short learning curve even in initial cohorts.

PO-683-06 MULTICENTER EXPERIENCE WITH ANDEXANET ALFA FOR REFRACTORY PERICARDIAL BLEEDING DURING CATHETER ABLATION OF ATRIAL FIBRILLATION IN PATIENTS TAKING FACTOR XA INHIBITORS

Pericardial bleeding is a rare but life-threatening complication of atrial fibrillation (AF) ablation. When significant pericardial bleeding occurs, protamine should be given to reverse heparin and pericardiocentesis performed. Patients taking uninterrupted oral anticoagulation (AC) are at increased risk for refractory pericardial bleeding. In such cases, andexanet alfa, a recombinant, inactive form of factor Xa, can be given to reverse oral AC. Clinical experience with andexanet in this setting has not yet been reported.

Catheter ablation in adult congenital heart disease on uninterrupted oral anticoagulation: Is it safe? Data from a large single-center study.

Catheter ablation in adult congenital heart disease (ACHD) patients is a critical treatment strategy for complex arrhythmias including atrial fibrillation (AF) and atrial tachycardia (AT). In addition to vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) are increasingly used in this patient population. The purpose of this study was to assess the safety of catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC, examining thromboembolic, bleeding, and vascular access complications. Retrospective analysis of 234 ACHD patients with simple (n = 83), moderate (n = 66), or complex (n = 85) CHD (mean age 46 years) undergoing 368 ablation procedures on uninterrupted oral anticoagulation with VKA (45.4%) or DOAC (54.6%) was undertaken. Arrhythmias were AF in 97, right AT in 181, left AT in 65, or a combination of AF and AT in25. No thromboembolic complications occurred. Major complications occurred in 4 patients (1.1%; 1 VKA, 3 DOAC), including retroperitoneal hematoma in 2 and arteriovenous (AV) fistula requiring surgical treatment in 2. Minor bleeding or vascular access complications occurred in 46 cases (12.5%), including hematomas >5 cm in 26, AV fistulas (not requiring surgical intervention) in 13, and pseudoaneurysms in 7 (thrombin injection in 3/7). Overall, no significant difference was found between DOAC (14.9%) and VKA groups (12.0%; P = .411). Catheter ablation in ACHD patients on uninterrupted oral anticoagulation with VKA or DOAC is feasible and safe. No thromboembolic events occurred, and major bleeding or vascular access complications were rare. No significant differences regarding minor bleeding or vascular access complications between patients on DOAC or VKA were found.

Is implantable cardioverter defibrillator surgery in patients with an implanted left ventricular assist device safe under uninterrupted oral anticoagulation?

Implantable cardioverter-defibrillator (ICD) surgery in patients with implanted left ventricular assist devices (LVAD) is associated with an increased risk of bleeding complications because of the need to ensure that these patients are adequately anticoagulated. Our study aimed to evaluate the safety of our new strategy of uninterrupted oral anticoagulation compared to heparin-bridging during the surgical interval. Between January 2009 and January 2020, 116 patients with LVAD underwent ICD surgery. Since January 2015, 60 patients were operated under continued sufficient oral anticoagulation with a vitamin k antagonist (VKA group). Fifty-six patients underwent a heparin-bridging regimen (heparin group). Demographics, perioperative data, complications, and mortality were analyzed. Bleeding complications attributable to the surgical intervention occurred more often (19.6% vs. 10.0%, p=0.142) and at a higher rate of re-exploratory surgery (14.3% vs. 5.0%, p=0.088) in the heparin group without reaching statistical significance. Moreover, the heparin group patients' postoperative total length of stay was 10days longer (17.8±23.8days vs. 8.3±9.5days, p=0.007). There were no procedure-related deaths, no thromboembolic events, and no LVAD-related thrombosis. Our strategy of uninterrupted oral anticoagulation is safe and results in a reduction by more than half the number of days in hospital without an increase in adverse events.

MRI-Detected Brain Lesions and Cognitive Function in Patients With Atrial Fibrillation Undergoing Left Atrial Catheter Ablation in the Randomized AXAFA-AFNET 5 Trial.

We aimed to assess the prevalence of ischemic brain lesions detected by magnetic resonance imaging and their association with cognitive function 3 months after first-time ablation using continuous oral anticoagulation in patients with paroxysmal atrial fibrillation (AF). We performed a prespecified analysis of the AXAFA-AFNET 5 trial (Anticoagulation Using the Direct Factor Xa Inhibitor Apixaban During Atrial Fibrillation Catheter Ablation: Comparison to Vitamin K Antagonist Therapy), which randomized 674 patients with AF 1:1 to uninterrupted apixaban or vitamin K antagonist therapy before first-time ablation. Brain magnetic resonance imaging using fluid-attenuated inversion recovery and high-resolution diffusion-weighted imaging was obtained within 3 to 48 hours after AF ablation in all eligible patients enrolled in 25 study centers in Europe and the United States. Patients underwent cognitive assessment 3 to 6 weeks before ablation and 3 months after ablation using the Montreal Cognitive Assessment (MoCA). In 84 (26.1%) of 321 patients with analyzable magnetic resonance imaging, high-resolution diffusion-weighted imaging detected at least 1 acute brain lesion, including 44 (27.2%) patients treated with apixaban and 40 (24.8%) patients treated with vitamin K antagonist (P=0.675). Median MoCA score was similar in patients with or without acute brain lesions at 3 months after ablation (28 [interquartile range (IQR), 26-29] versus 28 [IQR, 26-29]; P=0.948). Cerebral chronic white matter damage (defined as Wahlund score ≥4 points) detected by fluid-attenuated inversion recovery was present in 130 (40.5%) patients and associated with lower median MoCA scores before ablation (27 [IQR, 24-28] versus 27 [IQR, 25-29]; P=0.026) and 3 months after ablation (27 [IQR, 25-29] versus 28 [IQR, 26-29]; P=0.011). This association was no longer significant when adjusted for age and sex. Age was associated with lower MoCA scores before ablation (relative risk, 1.02 per 10 years [95% CI, 1.01-1.03]) and 3 months after ablation (relative risk, 1.02 per 10 years [95% CI, 1.01-1.03]). Chronic white matter damage as well as acute ischemic lesions detected by brain magnetic resonance imaging were found frequently after first-time ablation for paroxysmal AF using uninterrupted oral anticoagulation. Acute ischemic brain lesions detected by high-resolution diffusion-weighted imaging were not associated with cognitive function at 3 months after ablation. Lower MoCA scores before and after ablation were associated only with older age, highlighting the safety of AF ablation on uninterrupted oral anticoagulation. URL: https://www. gov; Unique identifier: NCT02227550.

Different Kinetics of Activated Clotting Time Among Uninterrupted Oral Anticoagulants During Catheter Ablation Procedure.

Activated clotting time (ACT) kinetics under uninterrupted oral anticoagulants (OACs) has not been fully evaluated. The present study is sought to validate ACT kinetics including stability under uninterrupted use of OACs during an ablation procedure in daily clinical practice. We prospectively enrolled consecutive 554 patients with atrial fibrillation who underwent catheter ablation procedure under uninterrupted OACs. We evaluated ACT kinetics at an interval of 15 minutes during the procedure and periprocedural complications among 5 OACs (dabigatran [N = 46], rivaroxaban [N = 125], apixaban [N = 129], edoxaban [N = 184], and warfarin [N = 70]). Compared with the dabigatran group, time to achieve target ACT was significantly longer in the rivaroxaban and apixaban groups, but not in the edoxaban and warfarin groups (8.7 vs 11.7 minutes, P < .001; 13.3 minutes, P < .001; 8.8 minutes, P = .64; 10.3 minutes, P = .19, respectively). Heparin dose to achieve target ACT was comparable except for the warfarin group, whereas, compared with the dabigatran group, time in therapeutic range of ACT within the first hour was comparable in the rivaroxaban and apixaban group but significantly lower in the edoxaban and warfarin groups (73.7 % vs 63.0%, P = .06; 67.0 %, P = .16; 59.2 %, P = .001; 58.2%, P = .004, respectively). In multiple regression analysis, low body weight, rivaroxaban, apixaban, and morning session had significant associations with time and heparin dose to achieve target ACT, and there were positive associations of dabigatran and apixaban with time in therapeutic range of ACT within the first hour. The incidence of periprocedural complications did not significantly differ among the 5 groups. Under uninterrupted OAC use in daily clinical practice, dabigatran showed faster achievement of target ACT and higher stability of ACT than other OACs.

Perioperative continuation of aspirin, oral anticoagulants or bridging with therapeutic low-molecular-weight heparin does not increase intraoperative blood loss and blood transfusion rate in cystectomy patients: an observational cohort study.

To assess if uninterrupted anticoagulant agents' administration affects blood loss and blood transfusion during open radical cystectomy (RC) and urinary diversion. We conducted an observational single-centre cohort study of a consecutive series of 1430 RC patients, between 2000 and 2020. Blood loss was depicted according to body weight and duration of surgery (mL/kg/h), and blood transfusion. The group 'with anticoagulant agents' was considered if surgery was performed with uninterrupted low-dose aspirin (ASS), oral anticoagulants (OAC) with an international normalised ratio (INR) goal of 2-2.5 or bridging with therapeutic low-molecular-weight heparin (LMWH). Outcomes were intraoperative blood loss, blood transfusion rate (separately analysed if administered within 24 h perioperatively or >24 h after surgery) and the 90-day major adverse cardiac events (MACE) rate. We used propensity score (PS)-matching analysis to adjust for imbalances between groups with or without anticoagulant agents. The PS-matched median (interquartile range [IQR]) blood loss was 2.10 (1.50-2.94) mL/kg/h in patients with anticoagulant agents vs 2.11 (1.47-2.94) mL/kg/h without anticoagulant agents (Padj > 0.99). The PS-matched blood transfusion rates were 26.2% vs 35.1% (Padj = 0.875) within 24 h perioperatively and 57.0% vs 55.0% (Padj = 0.680) if administered >24 h postoperatively. A sub-analysis of the three different anticoagulant agents could not detect any significance between ASS, OAC, or LMWH. The PS-matched incidence of MACE was 9.1% in the group with anticoagulant agents and 8.1% in those without anticoagulant agents (Padj > 0.99). Limitations include selection bias and retrospective analysis from prospectively assessed data. Perioperative continuation of ASS, uninterrupted OAC with low INR goal or bridging with LMWH had no impact on blood loss and transfusion rate in RC patients. Therefore, there might be no compulsory need for discontinuation of anticoagulant agents.

Postprocedural Radial Artery Compression Time In Chronic AnticoaguLated patients using StatSeal: The PRACTICAL-SEAL study

BackgroundPatients on uniterrupted chronic oral anticoagulation (OAC) therapy are at high-risk of bleeding during cardiac catheterization. We aimed to investigate the safety and efficacy of the StatSeal® disc for adjunct hemostasis in patients undergoing transradial coronary angiography under uninterrupted OAC therapy. MethodsPatients who underwent transradial cardiac catheterization without interrupted OAC therapy were included in this study. ResultsAmong 180 patients, 85 (47.2%) patients were on warfarin and 95 (52.8%) patients on novel oral anticoagulants (NOACs). Patients on NOACs were older (72.9 ± 9.6 versus 69.7 ± 10.8 years, P < 0.001) and had more atrial fibrillation/flutter (94.7% versus 62.4%, P < 0.001), whereas patients on Warfarin were more often women (43.5% versus 26.3%, P = 0.02) and had mechanical heart valves (27.1% versus 0%, P < 0.001). Intravenous unfractioned heparin (UFH) was administered in 96.5% of patients on warfarin (3799 ± 1342 units) and 93.7% patients on NOACs (4028 ± 1362 units), P = 0.27. There were no differences in terms of type and sheath size and the need for ad hoc coronary intervention. Time-to-first release of the hemostatic wristband was 56.2 ± 12.6 min and complete hemostasis was achieved in 71.1 ± 13.0 min, with shorter times among patients on NOACs (54.1 ± 11.7 and 58.5 ± 13.2 min, 68.9 ± 11.7 versus 73.6 ± 14.0 min, P = 0.02, for both). There were no significant differences in terms of bleeding. There was no radial artery occlusion among 112 participants who underwent color Doppler ultrasound. ConclusionThe present study shows that in patients undergoing transradial coronary angiogram under contemporary uninterrupted OAC therapy and periprocedural administration of UFH, the use of StatSeal® disc for adjunctive hemostasis was associated with short times to complete hemostasis.