Successful Left Atrial Appendage Closure Research Articles

Percutaneous left atrial appendage closure using a novel occlusion device for thromboembolic prevention: 3-year procedural experience

Abstract Background Stroke due to atrial fibrillation has been associated with a high risk of disability and mortality. Percutaneous left atrial appendage (LAA) closure has been established as a treatment strategy for stroke prevention in patients not eligible for oral anticoagulation as well as in patients after electrical isolation of the LAA and subsequent increased risk of thrombus formation. The aim of this study was to evaluate the feasibility and initial experience of LAA closure using a novel nitinol-based, self-expanding system in an unselected patient cohort. Methods and Results One hundred and two patients (39% female, median age 75 [71;80], median CHA2DS2-VASc score 5 [4;6]) underwent LAA closure with the novel system between October 2020 and October 2023. 61/102 (61%) patients underwent previous electrical LAA isolation, 30/102 (29%) patients had high bleeding risk as an indication for LAA closure. Median procedure time was 45 [38;59] minutes and median fluoroscopy time was 10 [7;12] minutes. Successful LAA closure was achieved in all patients, despite different LAA anatomies. Median umbrella and cover disc diameter were 22 [20;24] millimeter and 28 [20;24] millimeter, respectively. Procedure-related adverse events occurred in 2/111 (1.8%) patients. One patient had a vascular complication at the puncture site and another patient had non-hemodynamically significant pericardial effusion. Overall, the patients stayed for a median of 2 [1;4] days in hospital. Conclusion Left atrial appendage closure with a novel nitinol-based, self-expanding system is feasible and safe. LAA isolation was the most common indication for LAA closure at our institution. Further studies are needed, to identify differences and potential advantages of different LAA closure systems.

Efficacy of four different Left atrial Appendage closure techniques during cardiac surgery-A transesophageal echocardiography follow-up study

ObjectivesClosure of left- atrial appendage (LAA) is a routine part of AF ablation surgery and significantly reduces stroke rates. Different LAA closure techniques are used in cardiac surgery with variable results. We therefore evaluated the efficacy of four different LAA closure techniques in patients undergoing cardiac surgery. Methods149 patients who underwent concomitant LAA closure during cardiac surgery between 2015 and 2019 were included in this retrospective transesophageal echocardiography (TEE) study. Four different LAA closure techniques were evaluated: LAA clipping (n=62), suture ligation (n=28), stapler resection (n=30), surgical LAA excision (n=29). Successful LAA closure was defined as absence of LAA perfusion and absence of a stump >10 mm. ResultsThe mean patients age was 68.7 ± 9.4 years, 61.7% were male. No complications related to LAA closure were observed. Mean follow-up was 36.5±8 months. TEE follow-up showed the following LAA closure success rates: LAA clip 98.4%, surgical excision 93.1%, stapler resection 76.6% and suture ligation 39.2%. Suture ligation resulted in a high rate of recanalisation (50%) and residual stumps (10.8%), whereas stapler resection resulted in a high rate of residual stumps (23.4%). Overall, four patients (2.7%) had a stroke during follow-up. In detail, 2 of 27 (7.4%) patients with unsuccessful LAA closure had a stroke, whereas 2 of the 122 (1.6%) patients with successful LAA closure had a stroke. ConclusionsIn our study, LAA clipping and surgical LAA excision have proven to be both successful LAA closure methods. External LAA ligation and stapler resection resulted in low rates of successful LAA closure and should be avoided.

Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment.

Limited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure. This study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre- and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1-year follow-up CT. A total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre- and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency. Postprocedural CT at 45 days detected patent LAA in one-third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

Left atrial strain predicts the rhythm outcome in patients with persistent atrial fibrillation undergoing left atrial cryoablation during minimally invasive mitral valve repair.

Patients with atrial fibrillation (AF) have lower left atrial (LA) strain, which is a predictor for LA function. Here, we evaluated the prognostic value of LA strain to predict the rhythm outcome in patients with persistent AF undergoing LA cryoablation concomitant to minimally invasive mitral valve repair. Between 01/2016 and 12/2020, 72 patients with persistent AF underwent LA cryoablation during minimally invasive mitral valve surgery. All patients received a complete LA lesion set and left atrial appendage (LAA) closure with a clip. All patients received preoperative transthoracic echocardiography (TTE) with LA and left ventricular strain measurements. Preoperative LA and LV strain analysis was correlated with postoperative rhythm outcome. The mean age of the patients was 66.9 ± 7.2 years, of whom 42 (58%) were male patients. No major ablation-related complications occurred in any of the patients. Successful LAA closure was confirmed by intraoperative echocardiography in all patients. The 1-year survival rate was 97%. Freedom from AF at 12 months was 72% and 68% off antiarrhythmic drugs. Preoperative LA strain values were statistically significantly higher in patients with freedom from AF at 12 months of follow-up (12.7% ± 6.9% vs. 4.9% ± 4.1%, p = 0.006). Preoperative LV strain value was not associated with postoperative rhythm outcome. In multivariate logistic regression analysis, LA strain (p < 0.001) and AF duration (p = 0.017) were predictors for freedom from AF at 12 months of follow-up. In our study, LA strain analysis predicted the rhythm outcome in patients with persistent AF undergoing concomitant surgical AF ablation. In the future, LA strain might be a useful tool to guide decision-making on ablation strategies in patients with persistent AF.

Transcatheter Left Atrial Appendage Exclusion: Preclinical and Early Clinical Results With the Laminar Device

BackgroundThe Laminar device rotates and closes the left atrial appendage (LAA) using an integrated ball and lock that excludes and eliminates the LAA pouch. There is a low device surface area, minimizing the risk of peridevice leak (PDL) and device-related thrombus (DRT) formation. ObjectivesThis study evaluates the safety and efficacy of the Laminar LAA exclusion device in healthy animals and human subjects with nonvalvular atrial fibrillation at risk of ischemic stroke and systemic thromboembolism. MethodsThe preclinical study implanted the Laminar device into canine subjects that underwent transesophageal echocardiography (TEE) and fluoroscopic evaluation, followed by necropsy and histological assessment at 45 and 150-days post-implant. The early clinical study implanted the device in human subjects, followed to 12 months postimplantation. Procedural success was defined as device implantation in the intended location without residual LAA leak >5 mm as seen by TEE. Safety endpoints included freedom from stroke, systemic embolism, pericardial effusion, or tamponade, life-threatening/major bleeding, or death. ResultsThe Laminar device was successfully implanted in 10 canines. In all animals at 45 days and 150 days, no PDL or DRT was found, and histological examination showed fully closed LAAs covered with neo-endocardium. The device was successfully implanted in 15 human subjects with no safety events out to 12 months postimplantation. All subjects had successful protocol-defined LAA closure without DRT at 45 days by TEE and computed tomography, which remained stable through 12 months’ follow-up. ConclusionsThe preclinical and early clinical results demonstrate a promising safety and efficacy profile for the Laminar LAA exclusion device.

PO-02-134 REAL WORLD CLINICAL MANAGEMENT AFTER SURGICAL LEFT ATRIAL APPENDAGE EXCISION

Surgical left atrial appendage (LAA) closure is an increasingly utilized approach to mitigate the risk of cardioembolic stroke in patients with atrial fibrillation (AF). Optimal stroke prevention management after surgical LAA management with respect to imaging and continuation of oral anticoagulation (OAC) is not well understood. To elucidate real world clinical management of patients undergoing surgical LAA management. Over a 7-year period at a single center, 458 participants carried a diagnosis of AF and underwent surgical exclusion of their LAA during concomitant cardiac surgery. Clinical follow-up, including transesophageal echocardiography (TEE) data and OAC use were catalogued via chart review. Success of LAA ligation was defined as maximal stump depth < 1.0 cm (with no distal leak) in all dimensions imaged. Of the 458 participants, 115 (25%) had a post-operative TEE (with average post-operative time of 36 weeks). Of these 115 patients, 95 were discharged from cardiac surgery on OAC and 83/115 (72%) had successful LAA closure by TEE criteria; 19/115 had inadequate closure and 13/115 did not have sufficient image quality to assess LAA closure. Among the 83 patients with TEE-verified successful LAA closure, 7 had stroke during follow-up; of these strokes 3/7 occurred within 4 weeks of cardiac surgery. Only 1/7 patients was not on OAC at the time of their stroke. (Table 1) Among the 83 patients with successful LAA closure, 70 had been discharged on OAC following cardiac surgery. Of these 47/70 subsequently had their OAC discontinued; 43/47 of those discontinuations occurred after the TEE. Most patients undergoing surgical LAA management do not receive follow-up TEE imaging. When TEE is performed, surgical excision of the LAA is shown to have a moderate success rate. Clinical management after surgical LAA management, with regard to LAA imaging and OAC continuation, is highly heterogeneous.

Minimally invasive epicardial left-ventricular lead implantation and simultaneous left atrial appendage closure.

Atrial fibrillation (AF) is common in patients with heart failure resulting in a high prevalence of AF in patients receiving Cardiac Resynchronization Therapy (CRT) implantation. In patients, unsuitable for transvenous left ventricular (LV)-lead implantation, epicardial LV-lead implantation represents a valuable alternative. Epicardial LV-lead placement can be achieved totally thoracoscopical or via minimally invasive left lateral thoracotomy. In patients with atrial fibrillation, concomitant left atrial appendage (LAA) clipping is feasible via the same access. Therefore, the aim of our study was the analysis of safety and efficacy of epicardial LV lead implantation and concomitant LAA clipping via minimally invasive left-lateral thoracotomy. Between December 2019 and March 2022, 8 patients received minimally invasive left atrial LV-lead implantation with concomitant LAA closure using the AtriClip. Transesophageal echocardiography (TEE) was performed to intraoperatively guide and control LAA closure. Mean patients age was 64 ± 11.2 years, 67% were male patients. Minimally invasive left-lateral thoracotomy was used in 6 patients while a totally thoracoscopic approach was performed in 2 cases. Epicardial lead implantation was successfully performed in all patients with good pacing threshold (mean 0.8 ± 0.2 V) and sensing values (10.1 ± 2.3 mV). Posterolateral position of the LV lead was achieved in all patients. Furthermore, successful LAA closure was confirmed during TEE in all patients. No procedure-related complications occurred in any of the patients. Two patients additionally received simultaneous laser lead extraction during the same procedure. Complete lead extraction was achieved in both patients. All patients were extubated in the OR and had an uneventful postoperative course. Our study highlights a novel treatment approach for patients with atrial fibrillation and the necessity of epicardial LV leads. Placement of a posterolateral LV lead position with concomitant occlusion of the left atrial appendage via a minimally-invasive left-lateral thoracotomy or even a totally thoracoscopic approach is safe and feasible with superior cosmetic result and complete occlusion of the left atrial appendage.

Reduced- or Half-Dose Rivaroxaban Following Left Atrial Appendage Closure: A Feasible Antithrombotic Therapy in Patients at High Risk of Bleeding?

The optimal antithrombotic strategy after percutaneous left atrial appendage closure (LAAC) has not yet been established. The advisability of administering low-dose direct oral anticoagulation after LAAC to patients at high risk of bleeding is uncertain. Thus, in the present study, we evaluated the safety and effectiveness of reduced-(15 mg) or half-dose rivaroxaban (10 mg) versus warfarin regarding real-world risks of thromboembolism, bleeding, and device-related thrombosis (DRT) after LAAC. Patients with non-valvular atrial fibrillation and HASBLED ≥ 3 who had undergone successful LAAC device implantation from October 2014 to April 2020 were screened and those who had received 10 mg or 15 mg rivaroxaban or warfarin therapy were enrolled. The patients were followed up 45 days and 6 months after LAAC to evaluate outcomes, including death, thromboembolism, major bleeding, and DRT. Of 457 patients with HASBLED ≥ 3 who had undergone LAAC, 115 had received warfarin and 342 rivaroxaban (15 mg: N = 164; 10 mg: N = 178). There were no significant differences in the incidence of thromboembolism or DRT between the warfarin and both doses of rivaroxaban groups (all p > 0.05). The incidence of major bleeding was significantly higher in the warfarin group than in either the reduced- or half-dose rivaroxaban groups (warfarin vs. rivaroxaban 15 mg: 2.6% vs. 0%, p = 0.030; warfarin vs. rivaroxaban 10 mg: 2.6% vs. 0%, p = 0.038). Either reduced- or half-dose rivaroxaban may be an effective and safe alternative to warfarin therapy in patients with LAAC and who are at high risk of bleeding, the risk of thromboembolism being similar and of major bleeding lower for both doses of rivaroxaban.

Left Atrial Appendage Closure for Atrial Fibrillation in the Elderly >75 Years Old: A Meta-Analysis of Observational Studies

Background: Left atrial appendage closure (LAAC) is an established therapy for patients with atrial fibrillation (AF); however, there is a limited understanding of LAAC in elderly patients (≥75 years old). We conducted a meta-analysis to investigate the procedural complications and long-term outcomes after LAAC in the elderly versus the non-elderly. Methods: We screened PubMed, EMBASE, Cochrane Library, and Web of Science. Procedural endpoints of interest included successful implantation LAAC rates, in-hospital mortality, major bleeding events, pericardial effusion/tamponade, stroke, and vascular access complications related to LAAC. Long-term outcomes included all-cause mortality, major bleeding events, and stroke/transient ischemic attack (TIA) during follow-up. Results: Finally, 12 studies were included in the analysis; these included a total of 25,094 people in the elderly group and 36,035 people in the non-elderly group. The successful implantation LAAC rates did not differ between the groups, while the elderly patients experienced more periprocedural mortality (OR 2.62; 95% CI 1.79−3.83, p < 0.01; I2 = 0%), pericardial effusion/tamponade (OR 1.39; 95% CI: 1.06−1.82, p < 0.01; I2 = 0%), major bleeding events (OR 1.32; 95% CI 1.17−1.48, p < 0.01; I2 = 0%), and vascular access complications (OR 1.34; 95% CI 1.16−1.55, p < 0.01; I2 = 0%) than the non-elderly patients. The long-term stroke/TIA rates did not differ between the elderly and the non-elderly at least one year after follow-up. Conclusions: Even though successful implantation LAAC rates are similar, elderly patients have a significantly higher incidence of periprocedural mortality, major bleeding events, vascular access complications, and pericardial effusion/tamponade after LAAC than non-elderly patients. The stroke/TIA rates did not differ between both groups after at least one-year follow-up.

Delayed pericardial effusion or tamponade following left atrial appendage closure: A single-center experience

Pericardial effusion or pericardial tamponade (PE/PT) is a relatively common complication of left atrial appendage closure (LAAC). However, delayed PE/PT is rare with limited data. The aim of the study was to analyze the incidence and clinical consequences of delayed PE/PT following LAAC. Patients with nonvalvular AF who were successfully implanted with LAAC devices from October 2014 to April 2021 were consecutively screened. Subjects experiencing delayed PE/PT after LAAC were included. All treatment sessions of the subjects were recorded in detail. After discharge, the patients were followed up for clinical outcomes. A total of 748 patients with successful LAAC [nitinol cage device (475 Watchman 2.5), nitinol plug device (131 ACP and 142 LAmbre)] were screened. Six patients experienced delayed PE/PT (1 Watchman, 2 ACP, 3 LAmbre). The incidence of delayed PE/PT was higher in patients with a nitinol plug device (1.8% vs. 0.2%, P=0.027). Bloody PE only occurred in patients with a nitinol plug device (5/273, 1.8%). All the patients accepted pericardiocentesis and discontinuing antithrombotic medication, and none of the patients died or needed cardiac surgery. All patients were followed up for 810 (598, 1174) days after discharge. None of them developed constrictive pericarditis or thromboembolic or major bleeding events. Delayed PE/PT is rare but can occur, and the incidence of delayed bloody PE/PT for the nitinol plug device was higher than that for the nitinol cage device. The strategy of emergency pericardiocentesis combined with discontinuing antithrombotic medication may be effective for delayed bloody PE/PT.

Abstract 9688: Isoproterenol Assisted Differentiation Between Sludge and Organized Thrombus of Left Atrial Appendage to Help Guide Percutaneous Closure

Background: Percutaneous left atrial appendage (LAA) closure is contraindicated in patients with LAA thrombus. It can be challenging to distinguish slow flow (sludge) from organized thrombus on echocardiography. Recent case reports have shown that isoproterenol infusion can distinguish LAA sludge from thrombus, however, no mid/long-term outcome data exists. Methods: A retrospective study was conducted on 32 patients who underwent Watchman™ implantation at Piedmont Atlanta Hospital during 2021. Patients were divided into two groups, 1) clear LAA [Standard] and 2) suspected LAA thrombus versus sludge [Sludge]. The Sludge group underwent isoproterenol infusion prior to implantation of Watchman™ device. Data gathered included demographics, medical history, procedural data, and 6-months outcomes defined as TIA, CVA, or device related thrombus. Chi-square and T-test was used for statistical analysis. Results: The cohort had 8 patients (25%) in Sludge group with remaining 24 patients (75%) in Standard group. The Sludge group was younger at 73.5 years compared to 77.0 years for Standard group [p=0.02]. Other baseline characteristics including sex, comorbidities, and history of prior TIA/CVA were similar among both groups. Median CHA 2 DS 2 VASc Score was 5.0 for Standard and 4.5 for Sludge group [p= 0.21]. All patients in Sludge group had successful clearance with isoproterenol; median dose required was 6 mcg. LAA dimensions were similar with the median device size being 27 mm for both groups [p= 0.343]. At 45-day follow-up, one patient in Standard group had device related thrombus; it resolved on subsequent scan. At 6-months, one patient in Sludge group had experienced TIA; no patients underwent CVA. Conclusions: LAA thrombus is an absolute contraindication for percutaneous LAA device implantation, however, it can be difficult to differentiate between sludge and organized thrombus. This study demonstrates that intraprocedural isoproterenol infusion can be used to clear LAA sludge by improving LV contractility. No significant difference in mid-term outcomes was observed in our study groups, suggesting that isoproterenol assisted differentiation of LAA sludge from thrombus may allow successful LAA closure in cases that are deemed to have LAA sludge.

Amiloidosis cardiaca y cierre de aurícula izquierda. Estudio CAMYLAAC

Introduction and objectivesTransthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. MethodsComparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. ResultsWe studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. ConclusionsLAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.Full English text available from:www.revespcardiol.org/en

Clinical relevance of incomplete device endothelialization after left atrial appendage closure.

This study aimed to assess the incidence, potential risk factors and clinical impact of incomplete device endothelialization(IDE) after left atrial appendage closure (LAAC). A total of 101 consecutive patients with nonvalvular atrial fibrillation (AF) who underwent successful LAAC and received antithrombotic treatment using a standard regimen were prospectively followed up to 6 months after the procedure. The status of device endothelialization and device-related thrombus (DRT) were evaluated using cardiac computed tomography (CT). Major adverse cardio-cerebral events (MACCE) including all-cause death, heart failure(HF) hospitalization, acute ischemic stroke, transient ischemic attack(TIA), peripheral vascular embolism, and major bleeding were recorded. IDE was detected in 65 (64.4%) patients. Patients with IDE or complete device endothelialization (CDE) did not significantly differ with respect to baseline clinical characteristics and interventional procedure features. Multivariate analysis model revealed that persistent AF, left atrial appendage ostial diameter and left atrial size were independent risk factors for IDE. During 6-month follow-up, the incidence of DRT was 4.6% in patients with IDE and 2.8% in those with CDE, respectively (p > 0.05), and the overall rate of MACCE was non-significantly higher in the IDE group (7.7% vs. 2.8%, p = 0.32). IDE is common after LAAC, especially in patients with persistent AF, higher left atrial appendage ostial diameter and left atrial size. IDE confers an increased risk for DRT, but may be not necessarily associated with thromboembolic events and poor clinical outcome, providing careful monitoring and continued antithrombotic therapy are given.

Cardiac amyloidosis and left atrial appendage closure. The CAMYLAAC study

Introduction and objectivesTransthyretin cardiac amyloidosis (ATTR-CA) patients often have atrial fibrillation and increased bleeding/thrombogenic risks. We aimed to evaluate outcomes of left atrial appendage closure (LAAC) compared with patients without a known diagnosis of CA. MethodsComparison at long-term of patients diagnosed with ATTR-CA who underwent LAAC between 2009 and 2020 and those without a known diagnosis of CA. ResultsWe studied a total of 1159 patients. Forty patients (3.5%) were diagnosed with ATTR-CA; these patients were older and had more comorbidities, higher HAS-BLED and CHA2DS2-VASc scores, and lower left ventricular function. Successful LAAC was achieved in 1137 patients (98.1%) with no differences between groups. Regarding in-hospital and follow-up complications, there were no differences between the groups in ischemic stroke (5% vs 2.5% in those without a known diagnosis of CA; P=.283), hemorrhagic stroke (2.5% and 0.8% in the control group; P=.284), major or minor bleeding. At the 2-year follow-up, there were no significant differences in mortality (ATTR-CA: 20% vs those without known CA: 13.6%, 0.248); however, the at 5-year follow-up, ATTR-CA patients had higher mortality (40% vs 19.2%; P <.001) but this difference was unrelated to hemorrhagic complications or ischemic stroke. ConclusionsLAAC could reduce the risk of bleeding complications and ischemic cerebrovascular events without increasing the rate of early or mid-term complications. Although long-term survival was impaired in ATTR-CA patients, it was comparable to that of patients without a known diagnosis of CA at the 2-year follow-up, suggesting that LAAC for patients with ATTR-CA might not be futile.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

BackgroundVarious randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.AimsThe prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety.Methods and resultsThe total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.ConclusionsThe ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers.Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803.

Comparison of multiple imaging modalities for measuring orifice diameter and selecting occluder size in patients undergoing left atrial appendage closure.

BackgroundLeft atrial appendage (LAA) closure (LAAC) can safely and effectively prevent stroke events caused by atrial fibrillation. However, the structure of the LAA is highly variable among individuals, and the optimal method for obtaining measurements remains unknown.HypothesisWe aimed to study the accuracy of left atrial computed tomography angiography (CTA), three‐dimensional (3D) reconstruction using CTA, two‐dimensional transesophageal echocardiography (2D‐TEE), and digital subtraction angiography (DSA) for measuring the diameter of the LAA and compare their value for selecting occluder size.MethodsWe retrospectively evaluated data for 148 patients with nonvalvular atrial fibrillation who underwent successful LAAC. CTA and 2D‐TEE of the left atrium and pulmonary vein were performed before LAAC. We performed 3D reconstruction of the left atrium and LAA using Mimics and 3‐matics software. DSA of the LAA was performed during surgery.ResultsValues measured via CTA 3D reconstruction were significantly higher than those measured using other methods. DSA‐measured values were significantly lower than those measured via CTA and CTA 3D reconstruction. Occluder size was positively correlated with LAA orifice diameter. The differences between occluder size and DSA, 2D‐TEE, CTA, CTA 3D reconstruction measurements were 4.96 ± 2.58, 4.64 ± 2.50, 4.04 ± 1.37, and 2.92 ± 1.38 mm, respectively. Intraclass correlation coefficients for these methods were −.067, .006, .241, and .519, respectively.ConclusionCTA 3D reconstruction provides the best correlation and consistency between the measured LAA orifice diameter and occluder size. Adding 2–4 mm to the maximum LAA orifice diameter based on 3D‐CTA may aid in selecting the appropriate WATCHMAN device.

Early Discontinuation of Antithrombotic Treatment Following Left Atrial Appendage Closure

Although antithrombotic treatment is recommended after left atrial appendage closure (LAAC), some patients require discontinuation of antithrombotic treatment after LAAC without evidence on the safety of such a strategy. We sought to evaluate outcomes of patients who had early antithrombotic treatment discontinuation after LAAC. This is a multicenter study including 1,082 patients who underwent successful LAAC. Early discontinuation of antithrombotic treatment was defined as discontinuation of all antiplatelet/anticoagulant treatment within 6months following the procedure. A propensity-matched analysis was used to compare outcomes of patients with and without early antithrombotic treatment discontinuation. A total of 148 patients (13.7%) had early antithrombotic treatment discontinuation. In the entire population, antithrombotic treatment discontinuation patients exhibited a lower CHA2DS2-VASc score (p <0.001) and a higher rate of previous gastrointestinal bleeding episodes (p=0.01) compared with patients without discontinuation. After a median follow-up of 2.1(1,1-3.1) years after antithrombotic treatment discontinuation, the rates of death, ischemic stroke, and major bleeding were 12.1, 0.6, and 3.3 per 100 patient-years. In 119 matched pairs with similar baseline characteristics, antithrombotic treatment discontinuation patients had a similar risk of death (hazard ratio [HR] 1.06, 95% confidence interval [CI] 0.65 to 1.71, p=0.82), ischemic stroke (HR 0.39, 95% CI 0.04 to 3.79, p=0.42) and major bleeding (HR 1.48, 95% CI 0.56 to 3.88, p=0.43) compared with those without discontinuation. In conclusion, antithrombotic treatment was discontinued in 1 of 7 selected patients within 6months after LAAC, and this was not associated with an increased risk of death or thromboembolic events after a median follow-up of 2years. These data support the safety of shorter periods of antithrombotic therapy after LAAC in high bleeding risk patients based on clinician judgment. Further trials are warranted.

Outcome and safety of intracardiac echocardiography guided left atrial appendage closure within zero-fluoroscopy atrial fibrillation ablation procedures.

Simultaneous atrial fibrillation (AF) catheter ablation and left atrial appendage closure (LAAC) are sometimes recommended for both rhythm control and stroke prevention. However, the advantages of intracardiac echocardiography (ICE) guidance for this combined procedure have been scarcely reported. We aim to evaluate the clinical outcomes and safety of ICE-guided LAAC within a zero-fluoroscopy catheter ablation procedure. From April 2019 to April 2020, 56 patients with symptomatic AF underwent concomitant catheter ablation and LAAC. ICE with a multi-angled imaging protocol mimicking the TEE echo windows was used to guide LAAC. Successful radiofrequency catheter ablation and LAAC were achieved in all patients. Procedure-related adverse event rate was 3.6%. During the 12-month follow-up, 75.0% of patients became free of arrhythmia recurrences and oral anticoagulants were discontinued in 96.4% of patients. No ischemic stroke occurred despite two cases of device-related thrombosis versus an expected stroke rate of 4.8% based on the CHA2 DS2 -VASc score. The overall major bleeding events rate was 1.8%, which represented a relative reduction of 68% versus an expected bleeding rate of 5.7% based on the HAS-BLED score of the patient cohort. The incidence of iatrogenic atrial septal defect secondary to single transseptal access dropped from 57.9% at 2 months to 4.2% at 12 months TEE follow-up. The combination of catheter ablation and LAAC under ICE guidance was safe and effective in AF patients with high stroke risk. ICE with our novel protocol was technically feasible for comprehensive and systematic assessment of device implantation.

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.

Half-Dose Direct Oral Anticoagulation Versus Standard Antithrombotic Therapy After Left Atrial Appendage Occlusion.

This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation. No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure. After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events. Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-VASc [congestive heart failure, hypertension, age≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P=0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P=0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P=0.002). After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk ofthe composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based,antithrombotic therapy.