Contraindications For Oral Anticoagulation Research Articles

Prevalence of atrial fibrillation and reasons for undertreatment with oral anticoagulants

ObjectivesTo investigate the prevalence of atrial fibrillation (AF), the proportion of AF patients not receiving oral anticoagulation (OAC) and reasons for abstaining from OAC treatment.MethodsA retrospective cross-sectional study of patients aged 18 years or older with an AF diagnosis on June 1st 2020 in Västernorrland County, Sweden. AF diagnosis was retrieved using the ICD10 code I.48, and medical records were reviewed for comorbidities and documented reasons to abstain OAC treatment.ResultsOf 197 274 residents in Västernorrland County, 4.7% (9 304/197 274) had a documented AF diagnosis. Of these, 19% (1 768/9 304) had no OAC treatment, including 4.2% (393/9 304) with no indication, 2.5% (233/9 304) with a questionable and 2.5% (231/9 304) with a documented clear contraindication for OAC. In total 9.8% (911/9 304) were not treated with OAC despite indication and no reasonable documented contraindication, thus 90.8% (8 447/9 304) of all AF-patients were eligible for OAC treatment. Common reasons for abstaining treatment without reasonable contraindication were present sinus rhythm in 13.7% (125/911), perceived not an OAC candidate in 10.6% (97/911) and anemia in the past in 4.3% (39/911).ConclusionsIn the population of Västernorrland County, a very high AF prevalence of 4.7% was found, of which just over 90% would theoretically benefit from OAC treatment. This is higher than previously reported and stresses the importance of stroke prevention in this large patient group.

P112 CLINICAL OUTCOMES OF LEFT ATRIAL APPENDAGE OCCLUSION WITH CONSCIOUS SEDATION WITHOUT ANESTHESIOLOGIST ON SITE: RESULTS FROM A MULTICENTER RETROSPECTIVE STUDY

Abstract Background Left atrial appendage (LAA) occlusion is an important therapeutic option to prevent cardioembolic stroke in patients with atrial fibrillation (AF) with contraindications for oral anticoagulation (OAC). It is usually performed with transesophageal echocardiography (TOE) under general anesthesia (GA). In this retrospective study we present a multicenter experience of LAA occlusion performed with conscious sedation (CS) without anesthesiologist on site. Methods We collected all the LAA occlusion procedures performed from October 2018 to May 2022. All the included patients underwent the procedure for OAC intolerance mainly due to bleeding with irreversible causes. All the procedures were performed with Watchman or Amulet LAA occluders under TOE and fluoroscopy guidance by two expert interventional cardiologists without anesthesiologist on site. CS was performed with a combination of midazolam and fentanyl. Results One hundred and fifteen patients (age 76.4 ± 7.6 year) with non–valvular AF (median CHA2DS2Vasc 4.4 ± 1.4) were included in the study. CS was performed using midazolam (mean dose 5.9 ± 2.1 mg), adding fentanyl (mean dose 52.8 ± 19.6 mcg) in case of poor tolerance of the procedure despite midazolam. Acute procedural success rate was of 99.2%. One patient suffered a cardiac tamponade, urgent necessity of cardiac surgery and died 5 days after procedure. Two patients (2.6%) had anemia with need for transfusion after interventions. A patient (0.8%) suffered from oropharynx hematoma due to TOE. One case (0,8%) of vascular access site pseudoaneurysm occurred. One case (0.8%) of device thrombosis at 3 months TOE follow–up was reported. One procedure (0.8%) result in large leak device (³5 mm), confirmed at TOE follow–up performed at 3 months follow–up. No thromboembolic complications were reported. One hundred and fourteen (99.2%) patients stopped dual antiplatelet therapy within 12 months. In a follow–up of 10 ± 9 months one case of stroke (0.8%) and one case (0.8%) of transient ischemic attack (TIA) occurred. Conclusion LAA occlusion performed under CS and without the presence of anesthesiologist in cath–lab appear to be safe and effective. It can be an attractive alternative to (GA) because of lower medical staff needed and organizational effort required. In our retrospective study the success rate and the incidence of adverse events appear to be comparable with those of previous studies on the topic of LAA occlusion

Percutaneous left atrial appendage occlusion in patients with a cardiac implantable electronic device

BackgroundLeft atrial appendage occlusion (LAAO) may be a viable option for stroke prevention in patients with non-valvular atrial fibrillation and a contraindication for oral anticoagulation. No evidence evaluating the safety of this procedure in patients with a cardiac implantable electronic device (CIED) exists. The aim of this study was to evaluate whether CIED function is affected by LAAO and to explore LAAO procedural characteristics and complications in patients with a CIED.MethodsThis single-center cohort study included consecutive patients scheduled for percutaneous LAAO. Patients with a CIED prior to LAAO were selected and compared to the patients without CIED, concerning procedural characteristics and peri-procedural complications. In the group of patients with CIEDs, essential pacemaker integrity parameters were compared before and after the procedure to detect possible micro and macro lead displacements.ResultsThirty-one patients with CIED were scheduled for LAAO (age 73.7 ± 5.4 years, 65% males, CHA2DS2-VASc 4.3 ± 1.5, and HAS-BLED 3.3 ± 1.0). The 245 patients without CIED were younger, and HAS-BLED-score was slightly lower (69.4 ± 8.2 years, p < 0.001; 2.8 ± 1.0, p = 0.022). Patients without CIED more frequently underwent LAAO combined with catheter ablation (p = 0.002). All other procedural characteristics were comparable between both groups. No visible lead displacement was observed on chest X-ray after LAAO. Additionally, no differences in impedance, threshold, or intracardiac sensing in various CIED lead locations were found prior versus post LAAO.ConclusionThis study supports the feasibility and safety of LAAO in patients with a CIED.

Abstract P467: Left Atrial Appendage Occlusion and Risk of Stroke in Medicare Beneficiaries

Background: Atrial fibrillation (AF) is a significant risk factor for stroke, with oral anticoagulants (OACs) recommended for stroke prevention. However, a nonpharmacologic option is needed for patients with contraindications for OACs. Recently, percutaneous left atrial appendage occlusion (LAAO) has emerged as an alternative treatment option. Although clinical trials have shown that percutaneous LAAO is non-inferior to warfarin and direct OACs, few studies using real-world data have been done. Methods: Using data from the Medicare 20% sample databases (2015-18), we assessed the association between percutaneous LAAO vs. OAC use and risk of all stroke among patients with AF who had an elevated CHA 2 DS 2 -VASc score. Secondary outcomes included death and hospitalized bleeding. Patients undergoing percutaneous LAAO were matched with up to 5 other patients who were taking OACs by sex, age, date of enrollment, index date, and CHA 2 DS 2 -VASc score. A total of 17,514 patients with AF were matched (average [SD] 78 [6] years, 44% female). Cox proportional hazards model was used. Results: Over a median follow-up of 10.3 months, 293 stroke events, 1,925 deaths and 618 major bleeding events occurred. After multivariable adjustments, no significant difference for risk of stroke or death was noted when patients with percutaneous LAAO was compared to those taking OACs (HRs [95% CIs]: 1.25 [0.95, 1.67] and 0.94 [0.83, 1.06], respectively). However, there was a 3.24-fold (95% CI: 2.75, 3.81) increased risk for hospitalized bleeding after percutaneous LAAO compared to OAC. Conclusion: Using data from the Medicare 20% sample databases, no significant difference in risk of stroke or death were noted when percutaneous LAAO was compared to OAC users. However, there was an increased risk for bleeding. Our results confirm the results of randomized trials that among older patients with AF and a high-risk for stroke, percutaneous LAAO may be an alternative to OAC use; however, patients should be aware of potential risks associated with the implantation.

692 THE USE OF ULTRASOUND ENHANCING AGENTS (UEA) IN THE EVALUATION OF LEFT ATRIAL APPENDAGE (LAA) THROMBUS IN PATIENT CANDIDATE TO PERCUTANEOUS LAA CLOSURE

Abstract Introduction Left atrial appendage closure (LAAC) is an emerging option in patients with atrial fibrillation (AF) and contraindication for oral anticoagulation (OAC) therapy. Patients with left atrial thrombus are usually excluded from this strategy. Therefore, pre-procedural transesophageal echocardiography (TEE) is usually performed for LAA thrombus exclusion. The application of second-generation lipid microspheres ultrasound enhancing agents (UEA) is of growing interest. The following clinical cases reports describe the benefit from UEA implication on subsequent decision-making regarding with LAAC procedure. Case report num.1 an 88-year-old male with history of symptomatic AF and post – traumatic cerebral bleeding was referred to LAAC because of high risk of bleeding in using OAC. Transthoracic echocardiography (TTE) documented a severely dilatated left atrium and preserved left ventricular systolic function. Pre – operative TEE revealed a “chicken wing” shaped LAA with severe spontaneous echo-contrast and sludge effect. Echo-contrast medium “SonoVue” showed an early filling defect with late but complete LAA opacification, excluding thrombus. Of note, ECG-gated cardiac CT (CCT) could not exclude filling defect with certainty. Consecutively, the patient was candidate to LAAC in a short time. Case report num.2 a 75-year-old man with valvular permanent AF and multi-territory ischemic ictus despite being on adequate prophylactic OAC (Warfarin). At TTE a dilated left ventricle with mildly reduced ejection fraction was documented. ECG – gated CCT with delayed phases imaging showed a possible filling defect in LAA, however imaging was suboptimal due to a reverb of voluminous hiatal hernia. TEE revealed a “windstock” shaped LAA with incomplete distal opacification when echo-contrast medium “SonoVue” was used, confirming thrombus. The patient was therefore referred for LAAC procedure with concomitant use of cerebral embolic protection devices (CEPDs). Discussion Transesophageal echocardiography is the test of choice for the exclusion of LAA thrombus. However technical difficulty, spontaneous echo contrast (SEC) and prominent pectinate musculature within the appendage may make the exclusion of LAA thrombus not easy. ECG – gated cardiac CT may be conclusive as well. UEA use is associated with higher diagnostic power for LAA thrombus exclusion and recent study have shown its utility also in terms of LAA sizing. Thus, the most recent guidelines of American Society of Echocardiography mention echo contrast use for the delineation of LAA thrombi and differentiate between them with SEC. Conclusion The use of ultrasound enhancing agents is useful and increases the interpretative confidence in exclusion of LAA thrombus.

Trends in percutaneous left atrial appendage occlusion and 1-year mortality: a nationwide cohort study

Abstract Background Percutaneous left atrial appendage occlusion (LAAO) is increasingly used for stroke prevention in high-risk patients with atrial fibrillation and contraindication for oral anticoagulation. However, studies evaluating comorbidities and mortality remain scarce. Objectives The aim of this study was to evaluate changes in patient characteristic over time and 1-year risk of death. Methods Using Danish nationwide registers, we included all patients undergoing first-time LAAO between 2013 and 2021. To evaluate changes in patient characteristics, the study population was stratified according to calendar year of LAAO procedure: 2013–2015, 2016–2018, and 2019–2021. Baseline patient characteristics were defined from 10 years prior to date of LAAO procedure. Antithrombotic therapy was defined as claimed prescriptions within 180 days prior to LAAO procedure. Patients were then followed until either emigration, death, one year of full follow-up, or end of study period. Baseline frailty risk was estimated with The Hospital Frailty Risk Score, a validated frailty risk assessment tool based on ICD-10 codes. The 1-year unadjusted risk of death was estimated with the Aalen-Johansen method. Results In total, 1,306 patients underwent LAAO. The number of LAAO increased from 201 procedures in 2013–2015 to 586 in 2019–2021. During follow-up, the age of the patients remained stable (2013–2015: median age: 70 years; 2016–2018: median age 69 years; 2019–2021: median age 69 years). Fewer patients had a history of ischemic stroke (2013–2015: 44.3% vs 2019–2021: 27.6%), hemorrhagic stroke (2013–2015: 32.8% vs 2019–2021: 21.0%), and previous bleeding (2013–2015: 71.1% vs 2019–2021: 59.2%). Median CHA2DS2-VASs score decreased over time (2013–2015: 4 vs 2019–2021: 3) and same trend was found in median HAS-BLED score (2013–2015: 3 vs 2019–2021: 2). In addition, fewer patients were categorized as high frailty risk (2013–2015: 16.9% vs 2019–2021: 8.9%). However, there was an increase in patients with a history of cancer (2013–2015: 11.9% vs 2019–2021: 18.9%). The use of antiplatelet therapy prior to LAAO decreased while the use of oral anticoagulation increased (2013–2015: 50.2% vs 2019–2021: 68.9%) due to a marked increase in non-vitamin K antagonist oral anticoagulants and a decrease in vitamin K antagonists (Figure 1). In total, 88 (7.22%) patients died within one year of LAAO procedure. The 1-year all-cause mortality risk in each period were similar (2013–2015: 7.0%; 2016–2018: 7.1%; 2019–2021: 6.9%). [Figure 2] Conclusion In the years 2013–2021, the annual number of LAAO procedures increased. The age of patients remained stable. Comorbidity burden decreased and fewer patients were at high frailty risk, but the 1-year mortality risks were similar. Our real-life data suggest that profiles of patients undergoing LAAO has changed considerably over time. Funding Acknowledgement Type of funding sources: None.

Left atrial appendage exclusion in atrial fibrillation.

Although oral anticoagulants (OACs) are first-line therapy for stroke prevention in patients with atrial fibrillation (AF), some patients cannot be treated with OACs due to absolute or relative contraindications. Left atrial appendage (LAA) exclusion techniques have been developed over the years as a therapeutic alternative for stroke prevention. In this paper, we review the evolution of surgical techniques, employed as an adjunct to cardiac surgery or as a stand-alone procedure, as well as the recently introduced and widely utilized percutaneous LAA occlusion techniques. Until recently, data on surgical LAAO were limited and based on non-randomized studies. We focus on recently published randomized data which strongly support an add-on surgical LAAO in eligible patients during cardiac surgery and could potentially change current practice guidelines. In recent years, the trans-catheter techniques for LAA occlusion have emerged as another, less invasive alternative for patients who cannot tolerate oral anticoagulation. We review the growing body of evidence from prospective studies and registries, focusing on the two systems which are in widespread clinical use nowadays: the Watchman and Amulet type devices. These data show favorable results for both Watchman and Amulet devices, setting them as an important tool in our arsenal for stroke reduction in AF patients, especially in those who have contraindications for OACs. A better understanding of the different therapeutic alternatives, their specific benefits, and downfalls in different patient populations can guide us in tailoring the optimal therapeutic approach for stroke reduction in our AF patients.

Percutaneous Treatment Approaches in Atrial Fibrillation: Current Landscape and Future Perspectives.

Atrial fibrillation (AF), the most common sustained arrhythmia in clinical practice, represents a major cause of morbidity and mortality, with an increasing prevalence. Pharmacologic treatment remains the cornerstone of its management through rhythm and rate control, as well as the prevention of thromboembolism with the use of oral anticoagulants. Recent progress in percutaneous interventional approaches have provided additional options in the therapeutic arsenal, however. The use of the different catheter ablation techniques can now lead to long arrhythmia-free intervals and significantly lower AF burden, thus reducing the rate of its complications. Particularly encouraging evidence is now available for patients with persistent AF or concomitant heart failure, situations in which catheter ablation could even be a first-line option. In the field of stroke prevention, targeting the left atrial appendage with percutaneous device implantation may reduce the risk of thromboembolism to lower rates than that predicted with conventional ischemic risk scores. Left atrial appendage occlusion through the approved Watchman or Amplatzer devices is a well-established, efficacious, and safe method, especially in high-ischemic and bleeding risk patients with contraindications for oral anticoagulation.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

Left atrial appendage occlusion should be offered only to select atrial fibrillation patients.

COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”

Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications. This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands. The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use. NCT04676880.

Successful Left Atrial Appendage Closure with Watchman Device Implantation in Two Patients with Inferior Vena Cava Filters

Percutaneous procedures through femoral access in patients with inferior vena cava (IVC) filter may be at risk of complications. We evaluated the feasibility and safety of left atrial appendage closure (LAAC) through femoral access in patients previously implanted with IVC filter. We described the WatchmanTM device implantation in two patients with formal contraindication for oral anticoagulation. First patient had a GreenfieldTM filter and the second one an OpteaseTM filter, and in this patient an attempt to withdrawal the filter immediately before the LAAC procedure failed. A femoral approach was performed in both patients using a 14 Fr sheath. Before crossing IVC filters, venographies did not detect any thrombus. All steps of IVC filter crossing were performed under fluoroscopic guidance. No immediate or intrahospital complications related to the procedure occurred. Herein, we presented two cases of successful LAAC closure with Watchman device in patients with two different kinds of IVC filters.

Abstract 11107: Comparison of Left Atrial Appendage Occlusion and Direct Oral Anticoagulants and Warfarin in Patients with Atrial Fibrillation in Russian Prospective Registry

Introduction: Left atrial appendage occlusion (LAAO) is non-inferior to warfarin and direct oral anticoagulants (DOAC) in thromboembolic prophylaxis in atrial fibrillation (AF). However, these antithrombotic strategies in patients with and without contraindications to anticoagulants were not assessed separately before. Hypothesis: LAAO is superior to oral anticoagulants (OAC) in net clinical benefit in patients without contraindications for its usage, and superior to no thromboembolic prophylaxis in patients with contraindications for OAC. Methods: A prospective registry included 379 patients with nonvalvular AF and high risk of thromboembolic events. Patients were assigned into cohorts with and without contraindications to continuous therapy with OAC. In the first cohort patients with LAA occlusion (n=45), on DOAC (n=99) and on warfarin (n=100) were compared. In the second cohort patients with LAAO (n=75) were compared with those who received no antithrombotic prophylaxis (n = 60). The primary composite endpoint was net clinical benefit (all-cause mortality, ischemic stroke/transient ischemic attack/systemic embolism and major bleeding) in 3 years. Results: Using log-rank analysis of Kaplan-Meier curves in the cohort of patients without contraindications to OAC LAAO was superior to warfarin, reaching statistical significance (p=0.048), with a trend towards superiority over DOAC (p=0.061) . In the cohort of patients with contraindications to continuous OAC use, LAAO, in terms of both overall efficacy and safety, was significantly superior to no prophylaxis of thromboembolic events (p=0.003). (Figure 1). Conclusions: LAA occlusion demonstrated superiority to warfarin and no prophylaxis of thromboembolic events in terms of net clinical benefit. There was a trend to superiority of LAAO over DOAC in patients with contraindications to OAC.

An heart team stroke prevention decision-making process comparing percutaneous endocardial and thoracoscopic epicardial left atrial appendage occlusion

Abstract Introduction Left atrial appendage occlusion (LAAO) is a validated therapeutic option in patients with atrial fibrillation (AF) at high thrombo-embolic risk and contraindication to oral anticoagulation. Large clinical trials have demonstrated excellent efficacy of percutaneous LAAO, but also stand-alone thoracoscopic LAAO has shown promising results with the advantage of absence of antiplatelet therapy. No direct comparison of both strategies has been published yet. Purpose To evaluate an Atrial Fibrillation Heart Team guided approach to percutaneous or thoracoscopic left appendage exclusion in patients with non valvular atrial fibrillation (NVAF). Methods Forty patients with a contraindication to oral anticoagulation (OAC) were evaluated in the AF Heart Team for LAA exclusion. Contraindication for OAC was based upon a history of cerebral hemorrhages (n=17), non-cerebral life-threatening hemorrhages (n=9), repetitive bleeding (n=8) and having underlying diseases associated to high bleeding risk (n=6). The 20 patients included in the LAAO-Percutaneous group (LAAO-P) were on low molecular weight heparin pre-procedure, whereas in the LAAO-thoracoscopic group (LAAO-TT) none were on low molecular weight heparin nor antiplatelet therapy since the bleeding risk was estimated too high. The LAAO-P group were 70% male, with a mean age of 72.3±7.5 (range 57–82), mean CHA2DS2VASc 4.2 (range 1–6) and a mean HASBLED 3.5 (range 1–5) with an expected risk of bleeding between 3.7–8.7% per year. The LAAO-TT were 72.5% male, with a mean age of 74.9±8 (range 53–87 years), mean CHA2DS2-VASc 6.05 (range 4–8), HASBLED mean 5.4 (range3–8) expected risk of bleeding &amp;gt;12.5% per year. Variables considered were CHA2DS2VASc, HASBLED, documented blood transfusions, comorbidities related risk of bleeding, anatomy of the LAA, lung function, patient quality of life. LAAO-P patients were on dual antiplatelet therapy (DAT) at discharge for the first three months and aspirine 100mg/day thereafter, whereas the LAAO-TT patients were not. Follow up included TEE at 1 months and CT scan at 3 months. Results Mean duration of procedures for LAAO-P was 54.4 minutes, for LAAO-TT 52.01 minutes, mean post procedural ventilation time was respectively 11.2±6.4 and 15.8±16.4 minutes. No major complications occurred in both groups. One patient in the LAAO-P crossed over because of an unsuitable anatomy which became apparent intra-operatively. Mean hospital stay were comparable in both groups, 3.4±0.7 and 3.8±0.9 days respectively. At mean follow up of 24.3±10.1 months (range 5–36) all patients had complete exclusion of the appendage, no neurological events were reported. Conclusions The Heart Team can improve decision making in complex stroke prevention where LAAO is a therapeutic option, percutaneous and thoracoscopic occlusion seem to be comparably safe and effective. An epicardial LAAO could be advised in patients were the bleeding risk is estimated too high for AP therapy. Funding Acknowledgement Type of funding sources: None. Appendage closure: CT scan viewAppendage closure: surgical view

Left atrial appendage remodeling following percutaneous closure with WATCHMAN 2.5 and FLX: insights from the WATCH-DUAL registry

Abstract Background Percutaneous left atrial appendage closure (LAAC) has emerged as a valid option for prevention of thromboembolic events in patients with non-valvular atrial fibrillation and contraindications for oral anticoagulation. The most recent devices have been created to improve the intervention efficiency and to allow the procedure in a wider range of anatomies. The new-generation Watchman FLX (WMFLX) features a new design but its in vivo performances have not been compared to the previous WATCHMAN 2.5 (WM2.5) prosthesis. Hence, the data regarding conformability, compression and device-related LAA remodeling are scarce. Purpose To compare the anatomical results of WM2.5 and WMFLX implantation and impact on LAA dimensions. Methods This study included LAAC patients from the WATCH-DUAL registry who benefited from a pre- and post-intervention CT scan. The WATCH-DUAL study was a dual center observational study including all the LAAC procedures prospectively collected in local registries from two high-volume centres between November 2017 and December 2020. The LAA and device dimensions were measured in a centralized core lab by 3D CT scan reconstruction methods, focusing on the device landing zone (LZ/defined as the cross section of the appendage that was perpendicular to its axis and connected the circumflex artery to a point 1 to 2 cm inside the LAA). Results This analysis included n=107 patients (n=58 WMFLX, n=49 WM2.5). The patients clinical profiles didn't differ, except for a higher proportion of coronary artery disease in WM2.5 group. The LAA dimensions were comparable between groups. There was a significantly higher proportion of chickenwing shapes in the WMFLX patients. The mean device baseline diameter was in the WMFLX compared to the WM2.5 patients (28.8±0.5 vs. 25.7±0.4 mm, p&amp;lt;0.001). The median delay for CT control was 48 (43–62) days. The LZ area (451 (363–521) vs. 366 (260–459) mm2, p&amp;lt;0.001) and minimal diameter (23.0 (20.7–24.8) vs. 18.7 (15.9–21.8) mm, p&amp;lt;0.001) significantly increased after implantation among patients. The LZ area increase absolute value and percentage were 101 (18–151) mm2 and 28 (4–54) % respectively. The LZ dimensions increase was more pronounced in the WMFLX group: these patients exhibited post LAAC larger LZ area and dimensions compared to the WM2.5 cases. The LAA eccentricity was reduced after implantation: the ratio LZ maximal/LZ minimal diameter significantly decreased for all patients (r=1.28 (1.18–1.40) vs. 1.06 (1.05–1.09), p&amp;lt;0.001). Comparable results were observed in WMFLX and WM2.5 patients. A multivariable regression analysis demonstrated that baseline LAA length, baseline LZ eccentricity and WM FLX use were independent predictors of LAA remodeling/dimensions increase. Conclusion LAA dimensions increased over time at the site of WM prosthesis implantation suggesting a local positive appendage remodeling after procedure. This phenomenon appears to be more pronounced with the WMFLX device. Funding Acknowledgement Type of funding sources: None.

Two-Year Outcome From Combining Cryoballoon Ablation and Left Atrial Appendage Closure: CLACBAC Study.

Objective: Catheter ablation combined with left atrial appendage closure (LAAC) has emerged as a promising strategy for atrial fibrillation (AF) patients at high risk for stroke or with contraindications for oral anticoagulants (OACs). But the evidence for the long-term safety and efficacy of a combined procedure using cryoballoon ablation (CBA) with LAAC is still insufficient.Methods: From October 2015 to December 2017, a total of 76 consecutive non-valvular, drug-refractory AF patients who underwent a combined procedure of CBA and LAAC are included. Peri- and post-procedural safety and efficacy were evaluated through scheduled follow-ups and transesophageal echocardiography (TEE).Results: A total of 74 patients (97.4%) underwent the combined procedure and achieved instant pulmonary vein isolation and satisfactory LAAC. With a mean follow-up time of 23.7 ± 11.0 months, the recurrence of atrial arrhythmia was recorded in 35 patients (48.0%). In addition, a survival analysis shows a non-significant higher recurrence in persistent AF (p = 0.48). The overall OAC withdrawal rate was 97.2%, and one patient (1.4%) had a lethal hemorrhagic stroke while on single antiplatelet therapy. For safety concerns, the overall mortality was 2.7%, which resulted from one case of myocardial infarction on OAC and one hemorrhagic stroke, as mentioned. No other major hemorrhagic events occurred. Among the 72 patients (94.7%) who underwent TEE, one patient (1.4%) had device-related thrombosis and one patient (1.4%) had prominent residual flow (over 3 mm). Both were prescribed long-term OACs without severe complications occurring.Conclusions: Combining CBA with LAAC in a single procedure achieved considerable long-term safety and efficacy, providing a promising strategy for AF management.

Therapeutic management of nonvalvular atrial fibrillation

Atrial fibrillation (AF) is the most frequent persistent cardiac arrhythmia and is associated with an increased mortality. Therefore, an effective differential treatment of patients is mandatory. After a risk stratification oral anticoagulation (OAC) should be initiated depending on the individual stroke risk of each patient. Alternatively, in the presence of contraindications for OAC and an increased risk for bleeding and/or stroke, the implantation of a left atrial appendage closure device can be considered. Symptomatic patients should undergo arhythm control strategy if possible. Based on the risk-benefit considerations, catheter ablation (CA) of AF plays an increasingly important role in establishing long-term medicinal rhythm control. A pulmonary vein isolation can lead to freedom from AF for 1 year in 70-80% of patients with paroxysmal AF (and approximately 50% in persistent AF). So far, a survival advantage of CA could only be shown in patients with heart failure, so that in most cases this is only asymptomatic treatment for improvement in the quality of life.

Left atrial appendage occlusion in patients with atrial fibrillation and large prevalence of prior intracranial bleeding.

Left atrial appendage occlusion (LAAO) represents an alternative approach for the prevention of cardioembolic stroke in patients with nonvalvular atrial fibrillation (NVAF) and contraindication for oral anticoagulation (OAC). The aim of our study was to analyse the outcomes in patients treated with LAAO, with a focus on cases with previous intracranial bleeding. Sixty patients with NVAF underwent LAAO (75.4 ± 9 years); mean CHA2DS2-VASc was 4.4 ± 1.7, mean HAS-BLED 3.2 ± 0.9. Thirty-two patients (53.3%) reported previous intracranial bleeding. Ischaemic and bleeding events recorded during follow-up were compared with expected event rates according to CHA2DS2-VASc and HAS-BLED scores. Device implantation was successful in 58 patients (96.7%). The antiplatelet therapy was tailored according to patients' bleeding risk. During follow-up (2.32 ± 1.5 years) 3 ischaemic strokes and 1 transient ischaemic attack occurred, versus 13 total expected thromboembolic events (P = 0.033); 5 major bleedings were observed, versus 7 expected ones, if the patients were under OAC. Considering the combined endpoint (thromboembolic and major bleeding events) 9 events were observed versus 20 expected major events (P = 0.031). In the prespecified subgroup of patients with previous intracranial bleeding, two ischaemic strokes and one transient ischaemic attack were observed during follow-up versus six total expected thromboembolic events; no intracranial bleeding recurrence was recorded. Regarding the combined endpoint four major events were recorded versus nine expected ones. LAAO is an efficient and safe option for the prevention of cardioembolic stroke in patients with NVAF, high thromboembolic risk and contraindication to OAC, particularly in patients with previous intracranial bleeding.

Percutaneous left atrial appendage closure for stroke prevention in patients with chronic renal disease.

Atrial fibrillation (AF) is the most common cardiac arrhythmia in the general population. Atrial fibrillation is associated with an increased risk of thromboembolic events, particularly stroke. Chronic kidney disease (CKD) is associated with a higher prevalence of AF and is an independent risk factor of increased mortality and stroke in AF patients. Left atrial appendage closure (LAAC) for stroke prevention plays an important role in the treatment of patients with AF and increased bleeding risk. The impact of CKD on outcomes after LAAC has not been deeply investigated. We assessed whether percutaneous LAAC is safe and feasible in CKD patients. Ninety-seven patients (mean age: 73.9 ±8.5 years) with AF and contraindications for oral anticoagulation (OAC) or complications under OAC underwent LAAC with the Amplatzer Cardiac Plug and the Amplatzer Amulet Occluder in an open-label observational single-center study. We classified patients as having normal to mild (KDOQI stage I-II) or moderate to severe (KDOQI stage III-V) CKD. Patients with moderate to severe CKD (n = 49) had increased CHA2DS2-VASc and HAS-BLED scores and were at higher thromboembolic and bleeding risk (CHA2DS2-VASc: 4.08 ±0.79, HAS-BLED: 4.76 ±0.69) than patients with mild to moderate CKD (n = 48, CHA2DS2-VASc: 3.69 ±1.1, HAS-BLED: 4.06 ±0.66; p < 0.001 for both). In both groups, procedural and occlusion success was similar (97.9% vs. 95.9%; p = 0.479). Follow-up of 6 months and from 12 to 36 months revealed effective stroke prevention and no bleeding complication in both groups. In spite of a higher thromboembolic and bleeding risk in patients with severe CKD, LAAC is a safe and feasible option for stroke prevention.

DOES IMPLANTATION OF THE WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE DEVICE AFFECT LEFT ATRIAL PRESSURE IMMEDIATELY AFTER IMPLANTATION?

The WATCHMAN device is indicated for thromboembolic stroke prevention in patients with non-valvular atrial fibrillation who are at moderate to high stroke risk and have a contraindication for oral anticoagulation. It is unclear whether the implantation of the WATCHMAN left atrial appendage closure

LEFT ATRIAL APPENDAGE CLOSURE: ARE MEN AND WOMEN EQUAL? RESULTS FROM THE COBURG LAA OCCLUSION REGISTER

Left atrial appendage closure (LAAC) is an established treatment strategy to reduce the risk of stroke in patients with non-valvular atrial fibrillation and contraindications for oral anticoagulation. Sex and gender specific differences are increasingly important for all cardiovascular diseases and