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    Mechanical function of the left atrium is improved with epicardial ligation of the left atrial appendage: Insights from the LAFIT-LARIAT Registry. Dar Tawseef,Afzal Muhammad R,Yarlagadda Bharath,Kutty Shelby,Shang Quanliang,Gunda Sampath,Samanta Anweshan,Thummaluru Jahnavi,Arukala Kedareeshwar S,Kanmanthareddy Arun,Reddy Madhu,Atkins Donita,Bommana Sudharani,Dawn Buddhadeb,Lakkireddy Dhanunjaya Heart rhythm BACKGROUND:Left atrial (LA) strain (ε) and ε rate (SR) analysis by 2-dimensional speckle tracking echocardiography is a novel method for functional assessment of the LA. OBJECTIVE:The purpose of this study was to determine the impact of left atrial appendage (LAA) exclusion by Lariat epicardial ligation on mechanical function of the LA by performing ε and SR analysis before and after the procedure. METHODS:A total of 66 patients who underwent successful LAA exclusion were included in the study. Of these 66 patients, 32 had adequate paired data for ε and SR analysis. SR during ventricular systole (LA-SRs) represents LA reservoir function, and SR during early ventricular diastole (LA-SRe) represents LA conduit function. ε and SR were determined from apical 4- and 2-chamber views using the electrocardiographic QRS as a reference point. LA volume index as surrogate for LA remodeling was measured from apical views. RESULTS:Mean patient age was 70 ± 9.2 years. LAA ligation resulted in improved reservoir function (LA-SRs: pre 0.72, confidence interval [CI] 0.63-0.83 vs post 0.81, CI 0.73-0.98; P = .043) and conduit function (LA-SRe: pre 0.74, CI 0.67-0.99 vs post 0.89, CI 0.82-1.07; P = .025). LA volume index improved significantly with the Lariat (pre 35.4, CI 29.4-37.2 vs post 29.2, CI 28.2-35.9; P <.023). CONCLUSION:LAA exclusion seems to improve mechanical function of the LA and results in reverse LA remodeling. 10.1016/j.hrthm.2018.02.022
    A left atrial appendage closure combined procedure review: Past, present, and future perspectives. Gasperetti Alessio,Fassini Gaetano,Tundo Fabrizio,Zucchetti Martina,Dessanai Mariantonietta,Tondo Claudio Journal of cardiovascular electrophysiology BACKGROUND AND OBJECTIVE:Atrial fibrillation (AF) represents the most common cardiac arrhythmia worldwide; it poses a great burden in terms of quality of life reduction and yearly stroke risk. Left atrial appendage closure (LAAC) is a stroke prevention strategy that has been proven a viable alternative to antithrombotic regimens in nonvalvular AF patients. LAAC can be performed as a standalone procedure or alongside a concomitant AF transcatheter ablation, in a procedure known as "Combined procedure". Aim of this study is to summarize the scientific evidence backing this combined strategy. METHODS:We reviewed the whole Medline indexed combined procedure literature, to summarize all the combined procedure study data. RESULTS:Nine published studies regarding combined procedure were found. Data, aims, and scientific rationales were reported and commented. CONCLUSION:LAA combined procedure appears to be a safe and effective procedure; a careful patient selection is necessary to maximize its benefit. 10.1111/jce.13957
    The predictive value of a concise classification of left atrial appendage morphology to thrombosis in non-valvular atrial fibrillation patients. He Jionghong,Fu Zenan,Yang Long,Liu Wei,Tian Ye,Liu Qifang,Jiang Zhi,Tian Longhai,Huang Jing,Tian Shui,Zhao Yidong Clinical cardiology BACKGROUND:The complexity of left atrial appendage (LAA) in patients with nonvalvular atrial fibrillation (NVAF) is closely related to LAA thrombosis and stroke incidence. But the classification of LAA morphology is not uniform and controversial. HYPOTHESIS:This study divided the LAA into two categories according to the LAA morphology to investigate the risk of thrombosis related to the LAA structural complexity in NVAF patients. METHODS:A total of 336 NVAF patients were enrolled continuously in this study. The patients were divided into thrombosis group and non-thrombosis group according to whether the thrombus presence in LAA. Through computer LAA three-dimensional reconstruction, LAA morphology was divided into the complex type and simple type according to with or without the clearly lobulated structure judged by imaging experts. The relationship between LAA thrombosis and various potential risk factors was analyzed. RESULTS:A total of 19 potential risk factors for LAA thrombosis in NVAF patients were enrolled into statistical analysis. The coincidence rate of LAA morphology classification was 96.4% (324/336) between two imaging experts. Multivariate logistic regression analysis showed that complex LAA morphology (OR 4.168, 95% CI 1.871-9.288, P < .001) was associated with the presence of LAA thrombus, independently of other enrolled risks. CONCLUSIONS:It is a concise and reliable method to divide the LAA morphology into complex type and simple type according to whether with the clearly lobulated structure. The complex LAA is an independent risk factor for LAA thrombosis in NVAF patients. 10.1002/clc.23381
    Does left atrial appendage ligation during coronary bypass surgery decrease the incidence of postoperative stroke? Juo Yen-Yi,Lee Bailey Katherine,Seo Young-Ji,Aguayo Esteban,Benharash Peyman The Journal of thoracic and cardiovascular surgery OBJECTIVE:The study objective was to evaluate the association between surgical left atrial appendage ligation and in-hospital stroke incidence after coronary artery bypass grafting among patients with atrial fibrillation. METHODS:A retrospective cohort study was performed by using the Nationwide Inpatient Sample between 2008 and 2014. All atrial fibrillation patients who underwent coronary artery bypass graft were included and categorized as left atrial appendage ligation or control group. Propensity score-weighted regression analyses were performed to assess the impact of left atrial appendage ligation on stroke incidence. RESULTS:A total of 234,642 patients were identified, among whom 20,664 (8.81%) received concomitant left atrial appendage ligation. The national postoperative stroke incidence was 0.92%. Results of the propensity-weighted regression analysis showed no significant association between LAA ligation and control with regard to postoperative stroke (odds ratio [OR], 0.83; confidence interval [CI], 0.57-1.22; P = .35), pericardial complications (OR, 1.15; CI, 0.88-1.49; P = .31), hemorrhage and/or hematoma (OR, 1.08; CI, 0.99-1.17; P = .07), mortality (OR, 1.29; CI, 0.99-1.68; P = .06), and length of stay (coefficient -0.21; CI, -0.44-0.02; P = .08). There was no specific CHA2DS2VASC score cutoff above which left atrial appendage ligation was demonstrated to have lower postoperative stroke incidence. CONCLUSIONS:The postoperative stroke risk after coronary artery bypass grafting was low at approximately 1% among patients with atrial fibrillation in the United States. Concomitant left atrial appendage ligation was not associated with lower postoperative stroke risk. 10.1016/j.jtcvs.2018.02.089
    Impact of Left Atrial Appendage Exclusion on Short-Term Outcomes in Isolated Coronary Artery Bypass Graft Surgery. Mahmood Eitezaz,Matyal Robina,Mahmood Feroze,Xu Xinling,Sharkey Aidan,Chaudhary Omar,Karani Sadia,Khabbaz Kamal Circulation BACKGROUND:The objective of this study was to evaluate the impact of left atrial appendage (LAA) exclusion on short-term outcomes in patients with atrial fibrillation undergoing isolated coronary artery bypass graft surgery. METHODS:We queried the 2010 to 2014 National Readmissions Database for patients who underwent coronary artery bypass graft repair with and without LAA ligation by using procedure codes (: 36.1xx). Only patients with a history of atrial fibrillation were included in our analysis. The primary outcome of our study was 30-day readmissions following discharge. Secondary outcomes were in-hospital mortality and stroke. To assess the postoperative outcomes, we used multivariate logistic regression models to adjust for clinical and demographic covariates. RESULTS:In total, we analyzed 253 287 patients undergoing coronary artery bypass graft surgery, 7.0% of whom received LAA closure. LAA exclusion was associated with a greater risk of postoperative respiratory failure (8.2% versus 6.2%, <0.0001) and acute kidney injury (21.8% versus 18.5%, <0.0001), but it did not significantly change the rate of blood transfusions or occurrence of cardiac tamponade. LAA exclusion was associated with a nonsignificant reduction in stroke (7.9% versus 8.6%, =0.12), no difference in in-hospital mortality (2.2% versus 2.2% =0.99), and a greater risk of 30-day readmission (16.0% versus 9.6%, <0.0001). After covariate adjustment, LAA ligation remained a significant predictor of 30-day readmission (odds ratio, 1.640 [95% CI, 1.603-1.677], <0.0001). CONCLUSIONS:LAA exclusion during isolated coronary artery bypass graft surgery in patients with atrial fibrillation is associated with a higher rate of 30-day readmission. Postoperative measures to mitigate the loss of the hormonal and hemodynamic effects of the LAA may increase the therapeutic benefit of this procedure. 10.1161/CIRCULATIONAHA.119.044642
    Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Gloekler Steffen,Shakir Samera,Doblies Janosch,Khattab Ahmed A,Praz Fabien,Guerios Ênio,Koermendy Dezsoe,Stortecky Stefan,Pilgrim Thomas,Buellesfeld Lutz,Wenaweser Peter,Windecker Stephan,Moschovitis Aris,Jaguszewski Milosz,Landmesser Ulf,Nietlispach Fabian,Meier Bernhard Clinical research in cardiology : official journal of the German Cardiac Society BACKGROUND:Transcatheter left atrial appendage (LAA) occlusion has been proven to be an effective treatment for stroke prophylaxis in patients with atrial fibrillation. For this purpose, the Amplatzer cardiac plug (ACP) was introduced. Its second generation, the Amulet, was developed for easier delivery, better coverage, and reduction of complications. AIM:To investigate the safety and efficacy of first generation versus second generation Amplatzer occluders for LAA occlusion. METHODS:Retrospective analysis of prospectively collected data from the LAA occlusion registries of the Bern and Zurich university hospitals. Comparison of the last consecutive 50 ACP cases versus the first consecutive 50 Amulet cases in patients with non-valvular atrial fibrillation. For safety, a periprocedural combined endpoint, which is composed of death, stroke, cardiac tamponade, and bailout by surgery was predefined. For efficacy, the endpoint was procedural success. RESULTS:There were no differences between the two groups in baseline characteristics. The percentage of associated interventions during LAA occlusion was high in (78% with ACP vs. 70% with Amulet p = ns). Procedural success was similar in both groups (98 vs. 94%, p = 0.61). The combined safety endpoint for severe adverse events was reached by a similar rate of patients in both groups (6 vs. 8%, p = 0.7). Overall complication rate was insignificantly higher in the ACP group, which was mainly driven by clinically irrelevant pericardial effusions (24 vs. 14%, p = 0.31). Death, stroke, or tamponade were similar between the groups (0 vs. 2%, 0 vs. 0%, or 6 vs. 6%, p = ns). CONCLUSION:Transcatheter LAA occlusion for stroke prophylaxis in patients with atrial fibrillation can be performed with similarly high success rates with first and second generations of Amplatzer occluders. According to this early experience, the Amulet has failed to improve results of LAA occlusion. The risk for major procedural adverse events is acceptable but has to be taken into account when selecting patients for LAA occlusion, a preventive procedure. 10.1007/s00392-015-0828-1
    Percutaneous Closure of Left Atrial Appendage affects Mid-Term Release of MR-proANP. Behnes Michael,Sartorius Benjamin,Wenke Annika,Lang Siegfried,Hoffmann Ursula,Fastner Christian,Borggrefe Martin,Roth Thomas,Triebel Jakob,Bertsch Thomas,Akin Ibrahim Scientific reports The left atrial appendage (LAA) represents both a predisposing source of thrombus formation and of neuro-humoral haemostasis. This study aims to evaluate changes of biomarker expression before and after successful percutaneous closure of the LAA. Patients with atrial fibrillation and contraindication for oral anticoagulant therapy were enrolled. Blood samples were taken within 24 hours before (T1) and at least 6 months (mid-term) (T2) after successful implantation of LAA occlusion devices. Blood levels of high sensitivity troponin I and T (hsTnI, hsTnT), aminoterminal pro-brain natriuretic peptide (NT-proBNP) and mid-regional pro-atrial natriuretic peptide (MR-proANP) were evaluated at both time points. A total of 42 patients with successful percutaneous LAA closure were included. Median mid-term follow-up was of 183 days. HsTnT, hsTnI and NT-proBNP did not show any significant differences over time. Serum levels of MR-proANP increased significantly between immediate pre-intervention (T1: median = 245.7 pmol/l, IQR 155.8-361.3 pmol/l) and at mid-term follow-up (T2: median = 254 pmol/l, IQR 183.4-396.4 pmol/l) (p = 0.037). These results indicate, that percutaneous LAA closure affects neuro-humoral haemostasis by increasing MR-proANP serum levels at mid-term follow-up. 10.1038/s41598-017-08999-4
    Does left atrial appendage closure improve the success of pulmonary vein isolation? Results of a randomized clinical trial. Romanov Alexander,Pokushalov Evgeny,Artemenko Sergey,Yakubov Akmal,Stenin Ilya,Kretov Evgeny,Krestianinov Oleg,Grazhdankin Igor,Risteski Dejan,Karaskov Alexander,Steinberg Jonathan S Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing PURPOSE:The combination of left atrial appendage (LAA) occlusion with pulmonary vein isolation (PVI) potentially represents a comprehensive treatment for atrial fibrillation (AF), controlling symptoms while at the same time reducing the risk of stroke and the need for chronic anticoagulation. The aim of this randomized clinical trial was to assess the impact of LAA closure added to PVI in patients with high-risk AF. METHODS:Patients with a history of symptomatic paroxysmal or persistent AF refractory to ≥ 2 antiarrhythmic drugs, CHA2DS2-VASc score ≥ 2, and HAS-BLED score ≥ 3 were randomized to PVI-only (n = 44) or PVI with LAA closure (n = 45). RESULTS:Six patients in PVI + LAA closure group crossed over to PVI-only group due to failure of LAA closure device implantation. On-treatment comparisons at the 24 month follow-up revealed that 33 (66%) of the 50 PVI group and 23 (59%) of the 39 PVI with LAA closure group were AF-free on no antiarrhythmic drugs (p = 0.34). The PVI + LAA closure treatment was significantly associated with a higher AF burden during the blanking period: 9.7 ± 10.8 vs 4.2 ± 4.1% (p = 0.004). At the end follow-up, there were no serious complications and no strokes or thromboembolic events in either group. CONCLUSIONS:The combination of LAA closure device implantation with PVI was safe but was not observed to influence the success of PVI in patients with symptomatic refractory AF. Early AF after ablation, however, is increased by LAA closure. CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifier: NCT01695824. 10.1007/s10840-015-0030-4
    Feasibility and clinical efficacy of left atrial ablation for the treatment of atrial tachyarrhythmias in patients with left atrial appendage closure devices. Heeger Christian-Hendrik,Rillig Andreas,Lin Tina,Mathew Shibu,Deiss Sebastian,Lemes Christine,Botros Maichel,Metzner Andreas,Wissner Erik,Kuck Karl-Heinz,Ouyang Feifan,Tilz Roland Richard Heart rhythm BACKGROUND:Left atrial appendage (LAA) closure devices have been introduced recently as an alternative for oral anticoagulation (OAC) in patients with nonvalvular atrial fibrillation (AF). Because of potential overlap of ablation target areas and the previously implanted LAA closure device, as well as potential complications such as mechanical damage to the device, left atrial (LA) ablation remains a subject of debate in these patients. OBJECTIVE:We report on the feasibility and clinical efficacy of LA ablation after implantation of LAA closure devices. METHODS:Eight patients (6 men; age 69 ± 8 years) with symptomatic paroxysmal AF (n = 5) or persistent AF (mean CHA2DS2-VASc score 3.6 ± 0.7, mean HAS-BLED score 3.6 ± 1.5) and previously implanted WATCHMAN (7 patients) or AMPLATZER Cardiac Plug (1 patient) LAA closure devices received radiofrequency-based LA ablation (4 via circumferential pulmonary vein isolation [CPVI], 4 via CPVI and additional LA linear lesions or complex fractionated atrial electrograms) after a mean of 201 days (range 41-756 days) after LAA closure. RESULTS:Successful LA ablation was achieved without device interference or periprocedural complications. After a mean of 503 days (range 113-1006 days), transesophageal echocardiography (TEE) was performed in all patients to assess for device-related complications. No device dislocation or leakage was observed. In 1 patient (12.5%), a device-related thrombus was found despite therapeutic OAC with dabigatran. Five patients (63%) remained in stable sinus rhythm, and no bleeding events or stroke occurred during a follow-up of 554 days (range 218-1006 days). CONCLUSION:LA ablation after LAA closure appears to be feasible. Device-related thrombus formation in 1 patient suggests the need for further TEE examinations after LA ablation after LAA closure device implantation. 10.1016/j.hrthm.2015.03.011
    Impact of left atrial appendage occlusion on left atrial function-The LAFIT Watchman study. Murtaza Ghulam,Vuddanda Venkat,Akella Krishna,Della Rocca Domenico G,Sharma Sharan,Li Ling,Kutty Shelby,Turagam Mohit,Kar Saibal,Holmes David,Lakkireddy Dhanunjaya Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing BACKGROUND:Left atrial (LA) strain and strain rate (SR) analysis by two-dimensional speckle tracking echocardiography is a novel way of LA function assessment. From prior study, we know that LA appendage closure with LARIAT appears to improve LA function. OBJECTIVE:The purpose of this study was to assess the impact of LAA closure via Watchman device on LA function via strain and volumetric analyses using two-dimensional speckle tracking echocardiography (2D-STE). METHODS:Twenty-five patients who underwent Watchman device implantation (WDI) were included. LA function parameters (volumetric, strain indices) were calculated from apical four chamber views with the reference point set at QRS using 2D-STE before and after WDI. LA expansion index, strain and strain rate during ventricular systole represent LA reservoir function. Passive emptying fraction, strain and strain rate during early ventricular diastole represent LA conduit function. RESULTS:Mean age was 76 ± 6.9 years with 60% males. There was significant improvement in conduit function (LA passive emptying fraction; post 28.6 (21.9-35.9) vs pre 21.0 (13.8-34.7), p = 0.032), reservoir function (LA expansion index; post 75.3 (52.3-98.0) vs pre 58.1 (37.8-85.2), p = 0.026), and booster function (LA active emptying fraction; post 13.3 (9.7-29.9) vs pre 12.6 (8.8-25.5), p = 0.04) by volumetric indices. No significant improvement was noted with strain indices in conduit function (SRe; post - 0.56 (0.43-0.93) vs pre - 0.58 (0.46-0.87); p = 0.518) and reservoir function (SRs; post + 0.58 (0.28-0.40) vs pre + 0.52 (0.35-0.86); p = 0.851). CONCLUSIONS:WDI resulted in discrepancy of volumetric and strain indices in LA function assessment. 10.1007/s10840-019-00674-0
    Thoracoscopic Left Atrial Appendage Occlusion for Stroke Prevention Compared With Long-Term Warfarin Therapy in Patients With Nonvalvular Atrial Fibrillation. Gao Sophie Weiwei,Belley-Côté Emilie Prudence,Um Kevin John,Whitlock Richard Paul The American journal of cardiology 10.1016/j.amjcard.2019.02.003
    Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies. Tzikas Apostolos,Holmes David R,Gafoor Sameer,Ruiz Carlos E,Blomström-Lundqvist Carina,Diener Hans-Christoph,Cappato Riccardo,Kar Saibal,Lee Randal J,Byrne Robert A,Ibrahim Reda,Lakkireddy Dhanunjaya,Soliman Osama I,Näbauer Michael,Schneider Steffen,Brachman Johannes,Saver Jeffrey L,Tiemann Klaus,Sievert Horst,Camm A John,Lewalter Thorsten EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy. Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted. This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies. Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available. 10.4244/EIJV12I1A18
    Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. Tzikas Apostolos,Shakir Samera,Gafoor Sameer,Omran Heyder,Berti Sergio,Santoro Gennaro,Kefer Joelle,Landmesser Ulf,Nielsen-Kudsk Jens Erik,Cruz-Gonzalez Ignacio,Sievert Horst,Tichelbäcker Tobias,Kanagaratnam Prapa,Nietlispach Fabian,Aminian Adel,Kasch Friederike,Freixa Xavier,Danna Paolo,Rezzaghi Marco,Vermeersch Paul,Stock Friederike,Stolcova Miroslava,Costa Marco,Ibrahim Reda,Schillinger Wolfgang,Meier Bernhard,Park Jai-Wun EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology AIMS:To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). METHODS AND RESULTS:Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. CONCLUSIONS:In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events. 10.4244/EIJY15M01_06
    Percutaneous Left Atrial Appendage Occlusion for the Prevention of Stroke in Patients with Atrial Fibrillation: Review and Critical Appraisal. Schellinger Peter D,Tsivgoulis Georgios,Steiner Thorsten,Köhrmann Martin Journal of stroke The authors review the current status of percutaneous left atrial appendage (LAA) occlusion therapy in patients with atrial fibrillation with the goal to prevent ischemic stroke and systemic embolism and to reduce oral anticoagulation associated bleeding. While we cover the historical and also surgical background, and all tested devices, the main focus rests on the single currently U.S. Food and Drug Administration (FDA) approved LAA occluder, the WATCHMAN device, and its approval process. The authors also give a critical appraisal beyond the review of mere facts, trying to put the current data into perspective. 10.5853/jos.2018.02537
    Interventional left atrial appendage closure vs novel anticoagulation agents in patients with atrial fibrillation indicated for long-term anticoagulation (PRAGUE-17 study). Osmancik Pavel,Tousek Petr,Herman Dalibor,Neuzil Petr,Hala Pavel,Stasek Josef,Haman Ludek,Kala Petr,Poloczek Martin,Branny Marian,Chovancik Jan,Cervinka Pavel,Holy Jiri,Vancura Vlastimil,Rokyta Richard,Taborsky Milos,Kovarnik Tomas,Zemanek David,Peichl Petr,Haskova Sarka,Jarkovsky Jiri,Widimsky Petr, American heart journal Atrial fibrillation (AF), with a prevalence of 1% to 2%, is the most common cardiac arrhythmia. Without antithrombotic treatment, the annual risk of a cardioembolic event is 5% to 6%. The source of a cardioembolic event is a thrombus, which is usually formed in the left atrial appendage (LAA). Prevention of cardioembolic events involves treatment with anticoagulant drugs: either vitamin K antagonists or, recently, novel oral anticoagulants (NOAC). The other (nonpharmacologic) option for the prevention of a cardioembolic event involves interventional occlusion of the LAA. OBJECTIVE:To determine whether percutaneous LAA occlusion is noninferior to treatment with NOAC in AF patients indicated for long-term systemic anticoagulation. STUDY DESIGN:The trial will be a prospective, multicenter, randomized noninferiority trial comparing 2 treatment strategies in moderate to high-risk AF patients (ie, patients with history of significant bleeding, or history of cardiovascular event(s), or a with CHADSVASc ≥3 and HAS-BLED score ≥2). Patients will be randomized into a percutaneous LAA occlusion (group A) or a NOAC treatment (group B) in a 1:1 ratio; the randomization was done using Web-based randomization software. A total of 396 study participants (198 patients in each group) will be enrolled in the study. The primary end point will be the occurrence of any of the following events within 24months after randomization: stroke or transient ischemic attack (any type), systemic cardioembolic event, clinically significant bleeding, cardiovascular death, or a significant periprocedural or device-related complications. CONCLUSION:The PRAGUE-17 trial will determine if LAA occlusion is noninferior to treatment with NOAC in moderate- to high-risk AF patients. 10.1016/j.ahj.2016.10.003
    Occlusion of left atrial appendage affects metabolomic profile: focus on glycolysis, tricarboxylic acid and urea metabolism. Sattler K,Behnes M,Barth C,Wenke A,Sartorius B,El-Battrawy I,Mashayekhi K,Kuschyk J,Hoffmann U,Papavasiliu T,Fastner C,Baumann S,Lang S,Zhou X,Yücel G,Borggrefe M,Akin I Metabolomics : Official journal of the Metabolomic Society Background:Left atrial appendage (LAA) closure (LAAC) by implantation of an occlusion device is an established cardiac intervention to reduce risk of stroke while avoiding intake of oral anticoagulation medication during atrial fibrillation. Cardiac interventions can alter local or systemic gene and protein expression. Effects of LAAC on systemic metabolism have not been studied yet. Objectives:We aimed to study the effects of interventional LAAC on systemic metabolism. Methods:Products of glycolysis, tricarboxylic acid and urea metabolism were analyzed by ESI-LC-MS/MS and MS/MS using the AbsoluteIDQ™ p180 Kit in plasma of 44 patients undergoing successful interventional LAAC at baseline (T0) and after 6 months (T1). Results:During follow up, plasma concentrations of several parameters of glycolysis and tricarboxylic acid cycle (TCA) and urea metabolism increased (alanine, hexose, proline, sarcosine), while others decreased (aspartate, glycine, SDMA, serine). Multivariate linear regression analysis showed that time after interventional LAAC was an independent predictor for metabolite changes, including the decrease of SDMA (beta -0.19, p < 0.01) and the increase of sarcosine (beta 0.16, p < 0.01). Conclusions:Successful interventional LAAC affects different pathways of the metabolome, which are probably related to cardiac remodeling. The underlying mechanisms as well as the long term effects have to be studied in the future. 10.1007/s11306-017-1255-2
    Stroke risk reduction after left atrial appendage occlusion in elderly patients with atrial fibrillation: long‑term results. Litwinowicz Radosław,Bartuś Magdalena,Ceranowicz Piotr,Kapelak Bogusław,Lakkireddy Dhanunjaya,Bartuś Krzysztof Polish archives of internal medicine 10.20452/pamw.4264
    Feasibility and Safety of Left Atrial Appendage Closure Using the LAmbre Device in Patients with Nonvalvular Atrial Fibrillation with or Without Prior Catheter Ablation. Feng Xiang-Fei,Zhang Peng-Pai,Sun Jian,Wang Qun-Shan,Li Yi-Gang International heart journal Left atrial appendage (LAA) closure (LAAC) has emerged as an alternative therapeutic approach to medical therapy for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF). However, complex LAA anatomy may preclude its use. LAmbre is a new, self-expanding LAA occluder, and is highly adaptable to different LAA morphologies. We explored the feasibility, safety, and efficacy of LAAC using LAmbre device in NVAF patients with or without prior catheter ablation (CA). LAAC using LAmbre device was applied in NVAF patients with (group C) or without (group N) prior CA. Transesophageal echocardiography (TEE) was performed at 3, and 12 months post-LAAC. Among 17 LAAC patients (group C, 6 & group N, 11), 4 cases were implanted with special type devices, 5 were implanted with large devices. Besides one case of cardiac tamponade (N group), there were two minor peri-procedural complications only. Successful sealing of the LAA was documented in all the patients (100%) by TEE both post LAAC and at 3 months. At 3 months, no residual flow was achieved in 11 patients (64.7%); six patients (35.3%) had residual flow < 5 mm. There was no device dislocation or leakage during the mean of 30 months follow up. At 545 days after LAAC, one patient in group C experienced sudden death. Baseline, peri-procedural, and follow-up characteristics were similar between two groups (P > 0.05). LAAC with LAmbre device, subsequent to prior CA for AF, can be performed successfully and safely. The design and distinguishing features of this device could be of help in patients with complex anatomy of LAA. 10.1536/ihj.18-070
    Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. Holmes David R,Kar Saibal,Price Matthew J,Whisenant Brian,Sievert Horst,Doshi Shephal K,Huber Kenneth,Reddy Vivek Y Journal of the American College of Cardiology BACKGROUND:In the PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) trial that evaluated patients with nonvalvular atrial fibrillation (NVAF), left atrial appendage (LAA) occlusion was noninferior to warfarin for stroke prevention, but a periprocedural safety hazard was identified. OBJECTIVES:The goal of this study was to assess the safety and efficacy of LAA occlusion for stroke prevention in patients with NVAF compared with long-term warfarin therapy. METHODS:This randomized trial further assessed the efficacy and safety of the Watchman device. Patients with NVAF who had a CHADS2 (congestive heart failure, hypertension, age >75 years, diabetes mellitus, and previous stroke/transient ischemic attack) score ≥2 or 1 and another risk factor were eligible. Patients were randomly assigned (in a 2:1 ratio) to undergo LAA occlusion and subsequent discontinuation of warfarin (intervention group, n = 269) or receive chronic warfarin therapy (control group, n = 138). Two efficacy and 1 safety coprimary endpoints were assessed. RESULTS:At 18 months, the rate of the first coprimary efficacy endpoint (composite of stroke, systemic embolism [SE], and cardiovascular/unexplained death) was 0.064 in the device group versus 0.063 in the control group (rate ratio 1.07 [95% credible interval (CrI): 0.57 to 1.89]) and did not achieve the prespecified criteria noninferiority (upper boundary of 95% CrI ≥1.75). The rate for the second coprimary efficacy endpoint (stroke or SE >7 days' postrandomization) was 0.0253 versus 0.0200 (risk difference 0.0053 [95% CrI: -0.0190 to 0.0273]), achieving noninferiority. Early safety events occurred in 2.2% of the Watchman arm, significantly lower than in PROTECT AF, satisfying the pre-specified safety performance goal. Using a broader, more inclusive definition of adverse effects, these still were lower in PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial than in PROTECT AF (4.2% vs. 8.7%; p = 0.004). Pericardial effusions requiring surgical repair decreased from 1.6% to 0.4% (p = 0.027), and those requiring pericardiocentesis decreased from 2.9% to 1.5% (p = 0.36), although the number of events was small. CONCLUSIONS:In this trial, LAA occlusion was noninferior to warfarin for ischemic stroke prevention or SE >7 days' post-procedure. Although noninferiority was not achieved for overall efficacy, event rates were low and numerically comparable in both arms. Procedural safety has significantly improved. This trial provides additional data that LAA occlusion is a reasonable alternative to warfarin therapy for stroke prevention in patients with NVAF who do not have an absolute contraindication to short-term warfarin therapy. 10.1016/j.jacc.2014.04.029
    Prospective randomized evaluation of the watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: The PREVAIL trial. Belgaid Djouhar Roufeida,Khan Zara,Zaidi Mariam,Hobbs Adrian International journal of cardiology OBJECTIVES:Assessing the safety and effectiveness of left atrial appendage (LAA) (pouch found in the upper chambers of the heart) occlusion, using the Watchman device compared to long term warfarin therapy (drug that reduces clot formation), in preventing the risk of stroke in patients with atrial fibrillation (most common type of irregular heart beat). 90% of strokes in atrial fibrillation arise from clots forming in this pouch. By mechanically blocking it using the device less clots are suggested to be formed. This is an alternative to taking warfarin especially in patients who cannot take it. SETTING AND PARTICIPANTS:50 sites in the United States enrolled 407 participants. After being randomly allocated, the device group had 269 participants and warfarin group (comparator)had 138 participants. METHOD:Patients with atrial fibrillation and at high risk of stroke were randomly allocated a group after they were deemed eligible. Patients in the device group had to take warfarin and aspirin for 45days till the complete closure of the LAA. The oral anticoagulant was followed by dual antiplatelet therapy until 6months and then ASA. Patients in the warfarin group have to take it for life and were continually monitored. The study ran for 26months. MAIN OUTCOME MEASURES:The trial assessed the rate of adverse events using three endpoints: RESULTS:The PREVAIL trial was not designed to show superiority, but non-inferiority. It met the safety endpoint and one efficacy endpoint for the watchman device compared to long term warfarin for overall efficacy of the device. The results established that LAA occlusion is not worse than warfarin intake for the prevention of stroke more than 1week after randomization. Compared to previous trials, the safety of the device has also improved. CONCLUSION:LAA occlusion is a reasonable alternative to chronic warfarin therapy in stroke prevention for patients with atrial fibrillation. 10.1016/j.ijcard.2016.06.041
    Combination of catheter ablation for non-valvular atrial fibrillation and left atrial appendage occlusion in a single procedure. Li Xuexun,Li Jianping,Chu Hongxia,Wang Lihong,Shi Lei,Wang Guangqiang,Wang Xiaofei Experimental and therapeutic medicine Patients with atrial fibrillation (AF) have an increased risk of stroke and systemic embolism. Catheter ablation (CA) is increasingly applied for the treatment for drug-refractory AF; however, its long-term success rate is <50%. It has been proved that percutaneous left atrial appendage occlusion (LAAO) exerts the same efficacy as novel oral anti-coagulants [(N)OACs] in reducing thromboembolic events. The present study investigated whether a combined procedure of AF ablation and LAAO may be feasible and efficacious. CA was performed for patients with AF and a high risk of stroke according to their CHADS or CHADS-VASc score, and LAAO was performed using the Watchman device. A total of 25 patients (40% females; mean age, 64.2±3.5 years) who were treated between July 2016 and June 2017 were included in the present study. The median CHA2DS2-VASc score was 4.5 (range, 2-6) and the median HAS-BLED score was 3.17 (range, 1-7). Successful CA and LAAO were performed in 100% of cases. All patients met the criteria for successful LAAO. At the 6-month follow-up, complete sealing of the LAA was achieved in 23 patients (92%), while a minimal residual flow (<5 mm) was detected in 2 patients (8%). In 24 patients (96%), the administration of (N)OACs was terminated and aspirin administration was initiated at the 6-month follow-up. (N)OAC treatment was maintained in 1 patient (4%) on the basis of transient ischemic attack. During the 6-month follow-up period, 3 patients who had a recurrence of AF received a repeated ablation. In conclusion, the combination of CA and LAAO in a single procedure is feasible, safe and efficacious for patients with non-valvular AF at a high risk of stroke, and a contraindication regarding the use of (N)OACs. 10.3892/etm.2018.6358
    Device Sizing Guided by Echocardiography-Based Three-Dimensional Printing Is Associated with Superior Outcome after Percutaneous Left Atrial Appendage Occlusion. Fan Yiting,Yang Fan,Cheung Gary Shing-Him,Chan Anna Kin-Yin,Wang Dee Dee,Lam Yat-Yin,Chow Marco Chun-Kit,Leong Martin Chun-Wing,Kam Kevin Ka-Ho,So Kent Chak-Yu,Tse Gary,Qiao Zhiqing,He Ben,Kwok Ka-Wai,Lee Alex Pui-Wai Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography BACKGROUND:Left atrial appendage (LAA) occlusion is an alternative to anticoagulation for stroke prevention in patients with atrial fibrillation. Accurate device sizing is crucial for optimal outcome. Patient-specific LAA models can be created using three-dimensional (3D) printing from 3D transesophageal echocardiographic (TEE) images, allowing in vitro model testing for device selection. The aims of this study were to assess the association of model-based device selection with procedural safety and efficacy and to determine if preprocedural model testing leads to superior outcomes. METHODS:In 72 patients who underwent imaging-guided LAA occlusion, 3D models of the LAA were created from 3D TEE data sets retrospectively (retrospective cohort). The optimal device determined by in vitro model testing was compared with the actual device used. Associations of model-match and model-mismatch device sizing with outcomes were analyzed. In another 32 patients, device selection was prospectively guided by 3D models in adjunct to imaging (prospective cohort). The impact of model-based sizing on outcomes was assessed by comparing the two cohorts. RESULTS:Patients in the retrospective cohort with model-mismatch sizing had longer procedure times, more implantation failures, more devices used per procedure, more procedural complications, more peridevice leak, more device thrombus, and higher cumulative incidence rates of ischemic stroke and cardiovascular or unexplained death (P < .05 for all) over 3.0 ± 2.3 years after LAA occlusion. Compared with the retrospective imaging-guided cohort, the prospective model-guided patients achieved higher implantation success and shorter procedural times (P < .05) without complications. Clinical device compression (r = 0.92) and protrusion (r = 0.95) agreed highly with model testing (P < .0001). Predictors for sizing mismatch were nonwindsock morphology (odds ratio, 4.7) and prominent LAA trabeculations (odds ratio, 7.1). CONCLUSIONS:In patients undergoing LAA occlusion, device size selection in agreement with 3D-printed model-based sizing is associated with improved safety and efficacy. Preprocedural device sizing with 3D models in adjunct to imaging guidance may lead to superior outcomes. 10.1016/j.echo.2019.02.003
    Left atrial appendage occlusion in octogenarians: short-term and 1-year follow-up. Gafoor Sameer,Franke Jennifer,Bertog Stefan,Boehm Patrick,Heuer Luisa,Gonzaga Maik,Bauer Janine,Braut Annkathrin,Lam Simon,Vaskelyte Laura,Hofmann Ilona,Sievert Horst Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions OBJECTIVES:To determine the procedural safety, safety, and efficacy of left atrial appendage (LAA) occlusion in octogenarians. BACKGROUND:Elderly patients with atrial fibrillation (AF) often do not receive appropriate anticoagulation. LAA occlusion is an option for patients with AF and contraindications to anticoagulation. Not much is known about the procedural safety and clinical efficacy of LAA occlusion in the very elderly. METHODS:A retrospective review of LAA cases at our institution between 2002 and 2013 in patients 80 years of age or older was performed. Demographic, echocardiographic, procedural, and clinical follow-up data were collected. RESULTS:Seventy-five cases were attempted in patients 80 years of age or older (average age 83.4 ± 2.8 years, 53.3% males). Hypertension, coronary artery disease, and heart failure were present in 96, 41.3, and 36%, respectively. Mean CHADS2 and CHA2DS-VASc scores were 3.3 and 5.2. Devices used included the WATCHMAN, ACP, PLAATO, Lariat, and Coherex devices, which were attempted in 34.7, 36, 17.3, 5.3, and 5.3%, respectively. Overall procedural success, safety endpoint, and 1-year device efficacy was 90.1, 3.9, and 97.4%, respectively. CONCLUSION:LAA closure is a safe and efficacious method of stroke prevention in the very elderly with AF. 10.1002/ccd.25297
    Comparison of Efficacy and Safety of Left Atrial Appendage Occlusion in Patients Aged <75 to ≥ 75 Years. Freixa Xavier,Gafoor Sameer,Regueiro Ander,Cruz-Gonzalez Ignacio,Shakir Samera,Omran Heyder,Berti Sergio,Santoro Gennaro,Kefer Joelle,Landmesser Ulf,Nielsen-Kudsk Jens Erik,Sievert Horst,Kanagaratnam Prapa,Nietlispach Fabian,Gloekler Steffen,Aminian Adel,Danna Paolo,Rezzaghi Marco,Stock Friederike,Stolcova Miroslava,Costa Marco,Ibrahim Reda,Schillinger Wolfgang,Park Jai-Wun,Meier Bernhard,Tzikas Apostolos The American journal of cardiology Left atrial appendage occlusion (LAAO) is emerging as a promising alternative to oral anticoagulation. Because aged patients present a greater risk of not only cardioembolic events but also major bleeding, LAAO might represent a valid alternative as this would allow oral anticoagulation cessation while keeping cardioembolic protection. The objective of the study was to explore the safety and efficacy of LAAO in elderly patients. Data from the AMPLATZER Cardiac Plug multicenter registry were analyzed. The cohort was categorized in 2 groups (<75 vs ≥ 75 years). A total of 1,053 subjects were included in the registry. Of them, 219 were excluded because of combined procedures. As a result, 828 subjects were included (54.6% ≥ 75 years). Procedural success was high and similar in both groups (97.3%). Acute procedural major adverse events were not statistically different among groups (3.2% in <75 years vs 5.1%; p = 0.17) although stratified analysis showed a higher incidence of cardiac tamponade in elderly patients (0.5% vs 2.2%; p = 0.04). With a median follow-up of 16.8 months, no significant differences in stroke/TIA (1.9% vs 2.3%; p = 0.89) and major bleeding (1.7% vs 2.6%; p = 0.54) were observed. In conclusion, LAAO was associated with similar procedural success in patients aged <75 and ≥ 75 years although older patients had a higher incidence of cardiac tamponade. At follow-up, stroke and major bleeding rates were similar among groups. 10.1016/j.amjcard.2015.10.024
    Efficacy and safety of catheter ablation combined with left atrial appendage occlusion for nonvalvular atrial fibrillation: A systematic review and meta-analysis. Jiang Ying,Li Fanghui,Li Dongze,Cheng Yisong,Jia Yu,Fu Hua,Pu Xiaobo,Hu Hongde,Jiang Jian,Zeng Rui Pacing and clinical electrophysiology : PACE Atrial fibrillation (AF) is currently the most prevalent arrhythmia in clinical practice, with stroke being one of its major complications. Combining catheter ablation and percutaneous left atrial appendage occlusion (LAAO) into a "one-stop" intervention could reduce stroke incidence in selected high-risk patients and, at the same time, relieve AF symptoms in a single procedure. This meta-analysis analyzed the efficacy and safety of catheter ablation combined with LAAO for nonvalvular AF. PubMed, EMBASE, and the Cochrane Library were searched from inception to April 2019 to identify relevant citations. Efficacy indexes were procedural success, AF recurrence, stroke/transient ischemic attacks (TIA), and device-related thrombus (DRT). Safety indexes were all-cause death, major hemorrhagic complications, and pericardial effusion/cardiac tamponade. The incidence rate of events (ratio of events to patients) and 95% confidence interval (CI) were calculated as summary results. A forest plot was constructed to present pooled rates. Eighteen studies (two randomized controlled trials and 16 observational studies) were included. The results showed that one-stop intervention has significant efficacy and safety, with procedural success of .98 (95% CI, .97-1.00), AF recurrence of .24 (95% CI, .15-.35), stroke/TIA of .01 (95% CI, .00-.01), DRT of .00 (95% CI, .00-.01), all-cause mortality of .00 (95% CI, .00-.00), cardiac/neurological mortality of .00 (95% CI, .00-.00), major hemorrhagic complications of .01 (95% CI, .00-.02), and pericardial effusion/cardiac tamponade of .01 (95% CI, .00-.01). A single procedure with catheter ablation and LAAO in AF is a feasible strategy with significant efficacy and safety. 10.1111/pace.13845
    The efficacy of trans-esophageal echocardiography in treatment of nonvalvular atrial fibrillation with left atrial appendage occlusion. Song Y,Qin S-C,Fu X,Jiang Z-M,Chen K,Wang X-L,Zhang R-F,Liuang Y,Zhang R-F,Liu Y European review for medical and pharmacological sciences OBJECTIVE:To investigate the efficacy of transesophageal echocardiography (TEE) in the treatment of nonvalvular atrial fibrillation with left atrial appendage (LAA) occlusion. PATIENTS AND METHODS:Forty-nine patients with nonvalvular atrial fibrillation were selected from January 2015 to December 2015 to serve as control group, and 49 patients with nonvalvular atrial fibrillation were selected from January 2016 to December 2016 to serve as observation group. Patients in both groups were treated with LAA occlusion. After surgery, patients in control group received 2D-transesophageal echocardiography (2D-TEE), while patients in observation group received 3D-TEE. LAA diameter, maximum depth, postoperative parameters, and postoperative complications were compared between two groups. RESULTS:The maximum LAA diameter can be measured from different angles in control group, and maximum depth cannot be measured in control group. No significant differences in maximum LAA diameter and maximum depth were found between two groups from different angles (p<0.05). No significant difference in left ventricular end diastolic diameter (LVEDd), left atrial diameter (LA-d), left ventricular ejection fraction (LVEF), mitral regurgitation volume (MV Reg V), E peak and pulmonary vein diastolic flow velocity (PVd) were found between those two groups (p<0.05). The overall occurrence of postoperative complications in observation group and control group were 0.00% and 12.24%, respectively, significant difference was found between those two groups (p<0.05). CONCLUSIONS:Compared with 2D-TEE, the application of 3D-TEE in treatment of nonvalvular atrial fibrillation with left atrial appendage occlusion is more conducive to the selection of the size of the reservoir, and can reduce the occurrence of postoperative complications. 10.26355/eurrev_201808_15734
    Percutaneous left atrial appendage occlusion for stroke prophylaxis in nonvalvular atrial fibrillation: a systematic review and analysis of observational studies. Bajaj Navkaranbir Singh,Parashar Akhil,Agarwal Shikhar,Sodhi Nishtha,Poddar Kanhaiya Lal,Garg Aatish,Tuzcu E Murat,Kapadia Samir R JACC. Cardiovascular interventions OBJECTIVES:The goal of this study was to provide a systematic review and analysis of observational studies on percutaneous left atrial appendage (LAA) occlusion for stroke prophylaxis in nonvalvular atrial fibrillation (NVAF). BACKGROUND:A recent randomized controlled trial in patients with NVAF suggested noninferiority of percutaneous LAA occlusion versus medical management for stroke prevention. However, the use of percutaneous devices remains controversial because of limited literature on their efficacy and safety. We performed a systematic analytical review of existing observational studies to assess the rate of neurological events for patients treated with occlusion devices. METHODS:A comprehensive search of the Medline, Scopus, and Web of Science databases from inception through August 1, 2013, was conducted using pre-defined criteria. We included studies reporting implantation in at least 10 patients and a follow-up of 6 months or more. RESULTS:In 17 eligible studies, a total of 1,052 devices were implanted in 1,107 patients with 1,586.4 person-years (PY) of follow-up. The adjusted incidence rate of stroke was 0.7/100 PY (95% confidence interval [CI]: 0.3 to 1.1/100 PY), of transient ischemic attacks was 0.5/100 PY (95% CI: 0.1 to 1.8/100 PY), and of combined neurological events (strokes or transient ischemic attacks) was 1.1/100 PY (95% CI: 0.6 to 1.6/100 PY). Access site vascular complications and pericardial effusion were the most commonly observed procedural complications at a rate of 8.6% (95% CI: 6.3% to 11.7%) and 4.3% (95% CI: 3.1% to 5.9%), respectively. CONCLUSIONS:Our systematic review suggested comparable efficacy of LAA occlusion devices compared with historical controls treated with adjusted-dose warfarin and other anticoagulation strategies for prevention of stroke in patients with NVAF. 10.1016/j.jcin.2013.11.010
    Left Atrial Appendage Closure as an Alternative to Warfarin for Stroke Prevention in Atrial Fibrillation: A Patient-Level Meta-Analysis. Holmes David R,Doshi Shephal K,Kar Saibal,Price Matthew J,Sanchez Jose M,Sievert Horst,Valderrabano Miguel,Reddy Vivek Y Journal of the American College of Cardiology BACKGROUND:The risk-benefit ratio of left atrial appendage closure (LAAC) versus systemic therapy (warfarin) for prevention of stroke, systemic embolism, and cardiovascular death in nonvalvular atrial fibrillation (NVAF) requires continued evaluation. OBJECTIVES:This study sought to assess composite data regarding left atrial appendage closure (LAAC) in 2 randomized trials compared to warfarin for prevention of stroke, systemic embolism, and cardiovascular death in patients with nonvalvular AF. METHODS:Our meta-analysis included 2,406 patients with 5,931 patient-years (PY) of follow-up from the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) and PREVAIL (Prospective Randomized Evaluation of the Watchman LAA Closure Device In Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trials, and their respective registries (Continued Access to PROTECT AF registry and Continued Access to PREVAIL registry). RESULTS:With mean follow-up of 2.69 years, patients receiving LAAC with the Watchman device had significantly fewer hemorrhagic strokes (0.15 vs. 0.96 events/100 patient-years [PY]; hazard ratio [HR]: 0.22; p = 0.004), cardiovascular/unexplained death (1.1 vs. 2.3 events/100 PY; HR: 0.48; p = 0.006), and nonprocedural bleeding (6.0% vs. 11.3%; HR: 0.51; p = 0.006) compared with warfarin. All-cause stroke or systemic embolism was similar between both strategies (1.75 vs. 1.87 events/100 PY; HR: 1.02; 95% CI: 0.62 to 1.7; p = 0.94). There were more ischemic strokes in the device group (1.6 vs. 0.9 and 0.2 vs. 1.0 events/100 PY; HR: 1.95 and 0.22, respectively; p = 0.05 and 0.004, respectively). Both trials and registries identified similar event rates and consistent device effect in multiple subsets. CONCLUSIONS:In patients with NVAF at increased risk for stroke or bleeding who are candidates for chronic anticoagulation, LAAC resulted in improved rates of hemorrhagic stroke, cardiovascular/unexplained death, and nonprocedural bleeding compared to warfarin. 10.1016/j.jacc.2015.04.025
    Percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation: implantation and up to four years follow-up of the AMPLATZER Cardiac Plug. Santoro Gennaro,Meucci Francesco,Stolcova Miroslava,Rezzaghi Marco,Mori Fabio,Palmieri Cataldo,Paradossi Umberto,Pastormerlo Luigi Emilio,Rosso Gabriele,Berti Sergio EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology AIMS:Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited. METHODS AND RESULTS:LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%. CONCLUSIONS:LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores. 10.4244/EIJY14M10_13
    Reduction in risk of stroke and bleeding after left atrial appendage closure with LARIAT device in patients with increased risk of stroke and bleeding: Long term results. Litwinowicz Radoslaw,Bartus Magdalena,Kapelak Boguslaw,Suwalski Piotr,Lakkireddy Dhanunjaya,Lee Randall J,Bartus Krzysztof Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions BACKGROUNDS:Left atrial appendage occlusion (LAAO) offers an alternative to oral anticoagulation (OAC) for patients with atrial fibrillation (AF). The aim of this study was to present long-term clinical outcomes of LAAO in patients with a high risk of stroke and thromboembolic events (CHA DS -VAS-score ≥ 2) and bleeding (HAS-BLED score ≥ 2). MATERIAL AND METHODS:A prospective, single-center study was performed in 120 patients who were screened for LAAO with the LARIAT. Out of these 89 patients were underwent LARIAT placement, were 57 had high risk of thromboembolic and bleeding risk (LAA group). Control Group consisted of patients and 31 who screened out from the LARIAT and did not undergo LAAO. RESULTS:The mean CHA DS -VAS-score was 3.6 ± 1.5 versus 3.1 ± 1.2 and HAS-BLED score was 3.6 ± 1 versus 3 ± 1 compare LAA group versus control group. There were no thromboembolic events in the LAA group. In the control group thromboembolic events were observed in 9.6% (P = 0.017). Annual mortality rate was 1.8% in LAA group and 3.2% in control group (P < 0.05). Estimated bleeding risk reduction in LAA group was 62.2%. CONCLUSIONS:Long-term data confirmed that left atrial appendage closure with the LARIAT device is an effective and safe treatment in nonvalvular AF patients with high risk of stroke and bleeding. 10.1002/ccd.28187
    Left atrial appendage occlusion in patients with atrial fibrillation and high risk of fall: a clinical dilemma or a budgetary issue? D'Ancona Giuseppe,Safak Erdal,Ince Hüseyin Clinical research in cardiology : official journal of the German Cardiac Society 10.1007/s00392-019-01476-0
    Left atrial appendage occlusion versus standard medical care in patients with atrial fibrillation and intracerebral haemorrhage: a propensity score-matched follow-up study. Nielsen-Kudsk Jens Erik,Johnsen Søren Paaske,Wester Per,Damgaard Dorte,Airaksinen Juhani,Lund Juha,De Backer Ole,Pakarinen Sami,Odenstedt Jacob,Vikman Saila,Settergren Magnus,Kongstad Ole,Rosenqvist Mårten,Krieger Derk W EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology AIMS:The aim of this study was to investigate the prognosis in patients with atrial fibrillation (AF) and intracerebral haemorrhage (ICH) having a left atrial appendage occlusion (LAAO) versus patients receiving standard medical therapy. METHODS AND RESULTS:A total of 151 patients from the Nordic countries with AF and previous ICH who underwent LAAO using the AMPLATZER Cardiac Plug or the AMPLATZER AMULET were compared to a propensity score-matched group of 151 patients receiving standard medical therapy. The two groups were matched so that their risks for stroke and bleeding were similar (CHA2DS2-VASc and HAS-BLED scores). The standard care patients were identified from the Danish Stroke Registry among 787 patients with AF and ICH. The primary endpoint was a composite of all-cause mortality, ischaemic stroke and major bleeding. Patients with AF and a prior ICH treated with LAAO had a lower risk of the composite outcome as compared to patients treated with standard medical care (events/1,000 years [95% confidence interval]: 53.3 [44.3-64.1] vs. 366.7 [298.2-450.9]; hazard ratio 0.16 [0.07-0.37]). CONCLUSIONS:LAAO is suggested to be of major clinical benefit in AF patients having sustained an ICH. These results have to be confirmed in a randomised clinical trial. 10.4244/EIJ-D-17-00201
    Left atrial appendage occlusion: a critical appraisal updated with recent evidence. Mandrola John M,Foy Andrew J Current opinion in cardiology PURPOSE OF REVIEW:To allow readers to fully appreciate the uncertainties with this novel yet invasive approach to stroke prevention. RECENT FINDINGS:Percutaneous left atrial (LA) appendage occlusion has emerged as potential nonpharmacologic means to prevent stroke and systemic embolism in patients with atrial fibrillation. Yet the evidence underpinning this new technology is not definitive. SUMMARY:In this review, we consider the internal and external validity of the regulatory trials, pathophysiologic basis for LA appendage occlusion and clinical tradeoffs of the procedure. 10.1097/HCO.0000000000000698
    Residual leaks following percutaneous left atrial appendage occlusion: assessment and management implications. Raphael Claire E,Friedman Paul A,Saw Jacqueline,Pislaru Sorin V,Munger Thomas M,Holmes David R EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology Left atrial appendage (LAA) closure for stroke prevention in the setting of non-valvular atrial fibrillation is an alternative to oral anticoagulation in patients with increased bleeding risk. It allows similar reduction in thromboembolic events, in particular stroke, compared to warfarin. A common clinical dilemma is the management of patients with peri-device leak after LAA occlusion. This has been documented in both percutaneous as well as surgical approaches. The specific definitions of leak severity, and the longer-term clinical implications are poorly understood. Here we review the mechanisms of incomplete occlusion for the different percutaneous closure devices, the data regarding thromboembolic risk in patients with incomplete appendage closure for both percutaneous and surgical strategies, and provide recommendations for management in these patients. 10.4244/EIJ-D-17-00469
    The influence of iatrogenic interatrial septum leaks after left atrial appendage closure on cardiac function test results. Mitrega Katarzyna,Streb Witold,Szymala Magdalena,Podolecki Tomasz,Leopold-Jadczyk Anna,Morawski Stanislaw,Kalarus Zbigniew Journal of interventional cardiology AIM:Left atrial appendage occlusion (LAAO) is a technique for preventing thromboembolism in patients with atrial fibrillation and a high risk of irreversible bleeding. In some patients, a spontaneous iatrogenic transseptal leak (ITL) remains after LAAO. The aim of this study was to assess the correlation between ITL incidence and the results of cardiac function tests in patients who underwent LAAO. METHODS AND RESULTS:LAOO was performed in 62 consecutive patients using the Amplatzer Amulet. Before and 3 months after LAA occlusion, the 6-min walking distance (6MWD) test was performed in all patients and oxygen consumption assessment (VO ) was performed in 32. All patients had transesophageal echocardiography before and 3 months after LAAO to assess ITL incidence. The patients were divided according to the presence and absence of ITL and the subgroup of patients with heart failure (HF) were further analyzed. In patients with HF and ITL, an increased VO (12.8 ± 5.2 vs 15.3 ± 4.7; P < 0.05) and 6MWD (350.1 ± 77.4 vs 414.3 ± 70.6; P < 0.05) was observed after the procedure comparing to the results before the procedure. The 6MWD was also significantly higher in the patients with transseptal leaks in comparison to those without (P < 0.0001). CONCLUSION:The presence of transseptal leaks after LAAO does not influence overall cardiac function test results. However, in patients with HF, there is an increase in oxygen consumption and 6MWD. These results indicate that ITLs in patients with HF decrease left atrial pressure, which is the key contributor to the symptoms of heart failure during physical activity. 10.1111/joic.12531
    Left atrial appendage occlusion with the AMPLATZER Amulet device: one-year follow-up from the prospective global Amulet observational registry. Landmesser Ulf,Tondo Claudio,Camm John,Diener Hans-Christoph,Paul Vince,Schmidt Boris,Settergren Magnus,Teiger Emmanuel,Nielsen-Kudsk Jens Erik,Hildick-Smith David EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology AIMS:Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for patients with non-valvular atrial fibrillation (AF). This study reports one-year outcomes from patients enrolled in the prospective global Amulet registry. METHODS AND RESULTS:A total of 1,088 patients were recruited, aged 75±9 years; 65% of patients were male. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.6 and 3.3±1.1, respectively. Eighty-three percent (83%) of patients had contraindications to anticoagulation (OAC); 72% had a history of major bleeding. An AMPLATZER Amulet LAA occluder was successfully implanted in 99% of cases. Transoesophageal echocardiography one to three months after implant showed no residual flow or flow <3 mm in 98.4%. The observed ischaemic stroke rate was 2.9%/year. Device-related thrombus was noted in 1.7% of patients. There were ten cases between 0 and 90 days and eight cases between 91 and 365 days. Patients discharged without OAC (>80%), in particular those on single aspirin therapy, did not appear to have a higher risk of device-related thrombus. In the first year, major bleeding occurred at an annualised rate of 10.3%. All-cause mortality was 8.4% at one year. CONCLUSIONS:In the global prospective Amulet registry of patients at high risk of stroke and bleeding, the annualised ischaemic stroke rate was 2.9%. The LAA was sealed in 98.4% after one to three months and device-related thrombus was observed in 1.7% of cases with only a minority of all patients on anticoagulation treatment. 10.4244/EIJ-D-18-00344
    Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry. Brachmann Johannes,Lewalter Thorsten,Akin Ibrahim,Sievert Horst,Geist Volker,Zeymer Uwe,Erkapic Damir,Mudra Harald,Pleger Sven,Hochadel Matthias,Senges Jochen Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing BACKGROUND:Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE). METHODS:LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively. RESULTS:A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%). CONCLUSIONS:LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients. 10.1007/s10840-019-00635-7
    Left Atrial Appendage Occlusion in High Bleeding Risk Patients. Merella Pierluigi,Lorenzoni Giovanni,Delitala Alessandro P,Sechi Filomena,Decandia Federica,Viola Graziana,Berne Paola,Deiana Gianluca,Mazzone Patrizio,Casu Gavino Journal of interventional cardiology Objectives:The aim of this study was to investigate the outcomes of left atrial appendage occlusion (LAAO) in high bleeding risk patients suffering atrial fibrillation (AF) and to analyze the different antithrombotic therapies following the intervention. Background Methods:This monocentric study included 68 patients with nonvalvular AF with an absolute contraindication to OAT or at high bleeding risk. Follow-up was done with a clinical visit at 3-6-12 months. Results:Successful LAAO was achieved in 67/68 patients. At discharge, 32/68 patients were on dual antiplatelet therapy (APT), 34/68 were without any antithrombotic therapy or with a single antiplatelet drug, and 2/68 were on anticoagulant therapy. At three-month follow-up visit, 73.6% of the patients did not receive dual APT, of whom 14.7% had no thrombotic therapy and 58.9% were on single antiplatelet therapy. During a follow-up of 1.4 ± 0.9 years, 3/62 patients had late adverse effects (2 device-related thrombus without clinical consequences and 1 extracranial bleeding). The device-related thrombosis was not related to the antithrombotic therapy. Conclusions:LAAO is feasible and safe and prevents stroke in patients with AF with contraindication to oral anticoagulant therapy. After LAAO, single antiplatelet therapy seems to be a safe alternative to dual antiplatelet therapy, especially in patients at high bleeding risk. No benefit has been observed with dual APT. 10.1155/2019/6704031
    Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation and Previous Major Gastrointestinal Bleeding (from the Amplatzer Cardiac Plug Multicenter Registry). Lempereur Mathieu,Aminian Adel,Freixa Xavier,Gafoor Sameer,Shakir Samera,Omran Heyder,Berti Sergio,Santoro Gennaro,Kefer Joelle,Landmesser Ulf,Nielsen-Kudsk Jens Erik,Cruz-Gonzalez Ignacio,Kanagaratnam Prapa,Nietlispach Fabian,Ibrahim Reda,Sievert Horst,Schillinger Wolfgang,Park Jai-Wun,Gloekler Steffen,Tzikas Apostolos The American journal of cardiology History of major gastrointestinal (GI) bleeding may represent a frequent clinical indication for left atrial appendage occlusion (LAAO) in patients with non-valvular atrial fibrillation (AF). This study aims to investigate the procedural safety and long-term outcome of patients with previous major GI bleeding (MGIB) who underwent LAAO. Data from the Amplatzer Cardiac Plug multicenter registry on 1,047 patients were analyzed. Patients with previous MGIB as indication for LAAO were compared with patients without previous MGIB. A total of 151 patients (14.4%) with previous MGIB were identified. Periprocedural major bleeding events were more frequent in patients with previous MGIB (4.0% vs 0.8%, p = 0.001). With an average follow-up of 1.3 years, the observed annual rate of stroke/transient ischemic attack and major bleeding for patients with previous MGIB were 2.1% (61.4% relative reduction according to the Congestive Heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, Age 65-74, and Sex (female) [CHADS-VASc] score) and 4.6% (20.1% relative reduction according to the expected rate based on the Hypertension, Abnormal renal/liver function (1 point each), Stroke, Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs/alcohol concomitantly (1 point each) [HAS-BLED] score), respectively. In conclusion, in patients with non-valvular atrial fibrillation and previous MGIB, LAAO was associated with a low annual rate of stroke/transient ischemic attack. Periprocedural major bleeding events were more frequent in this specific population although the annual major bleeding rate showed a 20.1% relative risk reduction according to the HAS-BLED score. 10.1016/j.amjcard.2017.04.046
    Percutaneous left atrial appendage occlusion - treatment outcomes and 6 months of follow-up - a single-center experience. Karczewski Michał,Woźniak Sebastian,Skowronek Radomir,Burysz Marian,Fischer Marcin,Anisimowicz Lech,Demkow Marcin,Konka Marek,Ogorzeja Wojciech Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery AIM:To present the results of treatment and evaluate 6 months of follow-up in a group of patients with non-valvular atrial fibrillation, who underwent the procedure of percutaneous left atrial appendage occlusion (PLAAO). MATERIAL AND METHODS:Percutaneous left atrial appendage occlusion was performed in 34 patients with non-valvular atrial fibrillation and contraindications for oral anticoagulation therapy. The risk of thromboembolic and bleeding complications was determined based on the CHA2DS2VASc and HAS-BLED scales. The Amplatzer Amulet system from St. Jude Medical was used. On the first postoperative day, all patients were started on double antiplatelet therapy with 75 mg/day of acetylsalicylic acid (ASA) and 75 mg/day of clopidogrel (CLO). On the 30(th) postoperative day, the efficacy of the antiplatelet therapy was assessed with impedance aggregometry using a Multiplate analyzer (Roche). Echocardiographic examinations were performed intraoperatively and on the first postoperative day; subsequently, follow-up examinations were conducted 1 and 6 months after the implantation. RESULTS:In all patients, proper occluder position was observed throughout the follow-up. No leakage or thrombi around the implants were found. No strokes or bleeding complications associated with the antiplatelet therapy were observed. Multiplate assessment of platelet activity was conducted in 20 out of 34 patients. The efficacy of ASA treatment was demonstrated in all patients; no response to clopidogrel treatment was observed in 5 out of 20 patients. One patient suffered from cardiac tamponade, which required the performance of full sternotomy. Local complications (hematomas of the inguinal region) were observed in 3 patients. One of the patients died for reasons unrelated to the procedure. CONCLUSIONS:Percutaneous left atrial appendage occlusion is an effective procedure in patients with non-valvular atrial fibrillation and contraindications for chronic anticoagulation therapy. Further observation is necessary to evaluate the longterm results. 10.5114/kitp.2016.61041
    Characterization of Cerebrovascular Events After Left Atrial Appendage Occlusion. Freixa Xavier,Llull Laura,Gafoor Sameer,Cruz-Gonzalez Ignacio,Shakir Samera,Omran Heyder,Berti Sergio,Santoro Gennaro,Kefer Joelle,Landmesser Ulf,Nielsen-Kudsk Jens Erik,Kanagaratnam Prapa,Nietlispach Fabian,Gloekler Steffen,Aminian Adel,Danna Paolo,Rezzaghi Marco,Stock Friederike,Stolcova Miroslava,Paiva Luis,Costa Marco,Millán Xavier,Ibrahim Reda,Tichelbäcker Tobias,Schillinger Wolfgang,Park Jai-Wun,Sievert Horst,Meier Bernhard,Tzikas Apostolos The American journal of cardiology Cardioembolic strokes are generally more lethal and disabling than other source of strokes. Data from PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation) suggest that strokes after left atrial appendage occlusion (LAAO) with the Watchman device are less disabling than those in the warfarin group. No data assessing the severity of strokes after LAAO with the AMPLATZER Cardiac Plug (ACP) are available. The objective of the study was to evaluate the severity of cerebrovascular events after LAAO with the ACP in a population mostly characterized by an absolute or relative contraindication to oral anticoagulation. Data from the ACP multicenter registry were analyzed. Disabling strokes were defined as those with a modified Rankin score of 3 to 6 at 90 days after the event. A total of 1,047 subjects were included. The mean age and CHADS score were 75 ± 8 years and 2.8 ± 1.3, respectively. Procedural success was achieved in 97.3% and 4.9% of the patients presented procedural major adverse events. Clinical follow-up was complete in 98.2% of patients with a median of 13 months. There were 9 strokes (0.9%), 9 transient ischemic attacks (0.9%), and no intracranial hemorrhages (0%) at follow-up. After excluding 2 patients with pre-LAAO disability, functional assessment showed disabling events in 3 (19%) of the remaining 16 patients. The median time of presentation was 420 days (interquartile range 234 to 671) after LAAO, and 17 patients (94%) were on single-antiplatelet therapy when the event occurred. According to our results, cerebrovascular events after LAAO with the ACP system were infrequent and mostly nondisabling. 10.1016/j.amjcard.2016.08.075
    Intracardiac Versus Transesophageal Echocardiography for Assisting Percutaneous Left Atrial Appendage Occlusion?: "Veni, vidi, vICE"! Patti Giuseppe JACC. Cardiovascular interventions 10.1016/j.jcin.2019.04.031
    Causes of death and morbidity in patients with atrial fibrillation after left atrial appendage occlusion. Burysz Marian,Litwinowicz Radosław,Burysz Aleksandra,Ogorzeja Wojciech,Bartuś Krzysztof Kardiologia polska BACKGROUND:Left atrial appendage occlusion (LAAO) is a safe and effective alternative for stroke prevention in patients with atrial fibrillation (AF). However, there is little literature on the exact causes of death and adverse events during follow‑up after LAAO. AIMS:The primary aim of this study was to evaluate survival free of any serious adverse events and of any‑cause death in midterm follow‑up. The secondary aims were to analyze causes of mortality and further hospitalization as well as adverse events, thromboembolism, and bleeding risk reduction during follow‑up. METHODS:A retrospective, single‑center study was performed in 84 consecutive patients with AF who underwent LAAO with endocardial occluders. The mean (SD) CHADS2 score was 3.5 (1.1), CHA2DS2‑VASc score, 5.0 (1.5), and HAS‑BLED score, 4.4 (0.9). After LAAO, dual 6‑month antiplatelet therapy and then lifelong aspirin monotherapy was recommended. Mean (SD) follow‑up was 25.3 (13.2) months with an accumulated total follow‑up of 174.6 patient‑years. RESULTS:The annual mortality rate was 12.02%. More than half of deaths (57%) were due to noncardiovascular causes with leading malignancy. Survival at the end of the periprocedural period was 98.8%, at 3 months, 97.6%, at 6 months, 95.2%, at 12 months, 86.5%, at 18 months, 85.1%, and at 24 months, 80.6%. The average annual thromboembolic event rate was 2.87%. The most common adverse event was severe bleeding with an annual rate of 6.3% (3 cases while receiving dual antiplatelet therapy and 6 cases while receiving aspirin). CONCLUSIONS:The majority of deaths were not related to stroke in patients with AF after LAAO. Mortality in first 2 years following the procedure was predominantly from noncardiovascular causes. 10.33963/KP.14966
    Left atrial appendage morphology, echocardiographic characterization, procedural data and in-hospital outcome of patients receiving left atrial appendage occlusion device implantation: a prospective observational study. Fastner Christian,Behnes Michael,Sartorius Benjamin,Yildiz Mustafa,Mashayekhi Kambis,El-Battrawy Ibrahim,Lehmann Ralf,Baumann Stefan,Becher Tobias,Borggrefe Martin,Akin Ibrahim BMC cardiovascular disorders BACKGROUND:Implantation of left atrial appendage (LAA) occlusion devices was shown to be a feasible and effective alternative to oral anticoagulation in patients with non-valvular atrial fibrillation. However, only few data about in-hospital and peri-procedural data are currently available. This study aims to report about echocardiographic, procedural and in-hospital data of patients receiving LAA occlusion devices. METHODS:This single-center, prospective and observational study includes consecutively patients being eligible for percutaneous implantation of LAA occlusion devices (either Watchman™ or Amplatzer™ Cardiac Plug 2). Data on pre- and peri-procedural transesophageal echocardiography (TEE), implantation and procedure related in-hospital complications were collected. The primary efficacy outcome measure was a successful device implantation without relevant peri-device leaks (i.e., < 5 mm). RESULTS:In total, 37 patients were included, 22 receiving the Watchman™ and 15 ACP 2 device. Baseline characteristics did not differ significantly in both patient groups. The primary efficacy outcome measure was reached in 91.9% of patients (90.9% for the Watchman™, 93.3 % for the ACP 2 group). One device embolization (Watchman™ group) with successful retrieval occurred (2.7% of patients). No thromboembolism or device thrombosis were present. The majority of bleedings was caused by access site bleedings (88.3% of all bleedings), consisting mostly of mild hematomas corresponding to a BARC type 1 bleeding (80.0% of all access-site complications). One patient died due to septic shock (non-procedure related). CONCLUSIONS:In daily real-life practice, percutaneous treatment with LAA occlusion devices appears to be an effective and safe. 10.1186/s12872-016-0200-z
    Optimal combination strategy of left atrial appendage closure plus catheter ablation in a single procedure in patients with nonvalvular atrial fibrillation. Du Xianfeng,Chu Huimin,He Bin,Wang Binhao,Liu Jing,Feng Mingjun,Yu Yibo,Fu Guohua,Jin He,Gao Fang,Zhu Jingjing,Chen Xiaomin Journal of cardiovascular electrophysiology BACKGROUND:The efficacy and safety of combining left atrial appendage closure (LAAC) plus atrial fibrillation (AF) catheter ablation (CA) in a single procedure has been established, but the optimal combination strategy has not been thoroughly elucidated to date. OBJECTIVE:We aimed to investigate the impact of different combination strategies on clinical outcomes. METHODS:Eighty-two consecutive patients with symptomatic AF (mean CHA DS -VASc score 4.4 ± 1.4, mean HAS-BLED score 3.5 ± 1.0) were enrolled. LAAC with the Watchman device was performed either before (occlusion-first group, N  =  52) or after (ablation-first group, N  =  30) CA. Procedural and clinical data were retrospectively analyzed to evaluate the advantages of each strategy. RESULTS:Complete device occlusions were achieved in 92.3% and 90.0% of patients, respectively (P  =  0.719). Neither acute nor chronic peridevice leak greater than 5 mm was detected. Oral anticoagulants were held in all patients, except two (one in each group) with asymptomatic device-related thrombi. AF-free success rates were comparable between groups with a mean follow-up of 11.2 ± 7.3 months (75.0% vs. 70.0%, log-rank P  =  0.311). The new peridevice leak rate was significantly lower in the occlusion-first group (7.7% vs. 26.7%, P  =  0.019). Multivariate logistic regression demonstrated that the combination strategy was independently associated with the new peridevice leak (P  =  0.025, OR 13.3). CONCLUSIONS:Both occlusion-first and ablation-first strategies were efficacious and safe as combined procedures in patients with nonvalvular AF; however, the occlusion-first strategy was associated with lower new peridevice leak rates at follow-up. 10.1111/jce.13631
    Percutaneous left atrial appendage occlusion procedures in patients with heart failure. Szymała Magdalena,Streb Witold,Mitręga Katarzyna,Podolecki Tomasz,Mencel Grzegorz,Kukulski Tomasz,Kalarus Zbigniew Kardiologia polska BACKGROUND:Atrial fibrillation (AF) is the most common supraventricular tachyarrhythmia. Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with nonvalvular AF (NVAF), especially in contraindications for oral anticoagulants (OAC) or high risk of bleeding. The data about implantation, safety, efficacy, and follow-up are limited. Moreover, there are no studies on patients with NVAF and heart failure with severe left ventricular systolic dysfunction (left ventricular ejection fraction [LVEF] ≤ 35%). AIM:To assess the safety, efficacy, and mid-term outcomes of LAAO procedures with Amplatzer Cardiac Plug (ACP) and Amplatzer Amulet device in patients with NVAF and heart failure with LVEF ≤ 35% (group I) and to perform a comparative analysis of the patients who had LAAO with NVAF and LVEF > 35%. METHODS:The analysis included 80 patients (group I: 19, group II: 61) with NVAF. The patients were enrolled for the study if they had: CHA2DS2VASc ≥ 2 and high risk of bleeding assessed in HAS-BLED (≥ 3) or less points in HAS-BLED but coexisting contraindications for OAC, or thromboembolic complications while using OAC. Time of follow-up was six months. RESULTS:In the studied population, the median CHA2DS2VASc score was 4 and the average HAS-BLED score was 3.2. Device implantation was successful in all patients from group I and in 59/61 patients from group II. The periprocedural clinical ef-ficacy (no thromboembolic complications) was 100% in group I and 98.4% in group II. Serious periprocedural complications (cardiac tamponade: 2.5%, device embolisation: 1.25%, unexplained death: 1.25%) occurred only in patients from group II (p = NS). The mid-term clinical efficacy was 100% in group I and 98.3% in group II (p = NS). During follow-up, one transient ischaemic attack and three deaths not related to the procedure occurred. CONCLUSIONS:Percutaneous LAAO is an effective and safe procedure in patients with NVAF and severe systolic heart failure. No significant periprocedural and mid-term differences, in terms of safety and efficacy, between the group with severe systolic heart failure (LVEF ≤ 35%) and the group without severe left ventricular systolic dysfunction (LVEF > 35%) were found. 10.5603/KP.a2017.0115
    Left Atrial Appendage Transcatheter Occlusion with AMPLATZER™ Amulet™ Device: Real Life Data with Mid-Term Follow-Up Results. Şahiner Mehmet Levent,Kaya Ergun Baris,Çöteli Cem,Aytemir Kudret Arquivos brasileiros de cardiologia BACKGROUND:Left atrial appendage (LAA) occlusion is an alternative therapy for atrial fibrillation patients who have high embolic risk and contraindications to anticoagulant therapy. OBJECTIVE:To evaluate the feasibility, safety, and mid-term outcomes of percutaneous LAA occlusion, including device-related thrombosis. METHODS:Sixty consecutive patients who had undergone percutaneous LAA occlusion with AMPLATZER™ Amulet™ device from September 2015 to March 2018 were enrolled. Patients were followed for 21 ± 15 months (median - 20 months, interquartile range - 9 to 27 months). The postprocedural assessment was done at the 1(st), 6(th), and 12(th) month. Patients were clinically evaluated, and transesophageal echocardiography was performed at each visit. We evaluated the condition of normality of variables using the Kolmogorov-Smirnov test. P-values < 0.05 were statistically significant. RESULTS:The most common indication for the procedure was major bleeding with anticoagulants (n: 53, 88.3%). The procedure was completed successfully in 59 (98.3%) patients. Periprocedural mortality was observed in one patient. Postprocedural antiplatelet treatment was planned as dual or single antiplatelet therapy or low-dose anticoagulant therapy in 52 (88.1%), 2 (3.4%), and 5 (8.5%) patients, respectively. We found no clinically significant cerebrovascular events, device-related thrombus, or embolization in any patient during the follow-up. Two (3.4 %) patients presented significant peri-device leak (>3 mm) at the 1st month evaluation, which disappeared at the 12th month follow-up. CONCLUSION:We concluded that LAA occlusion using the Amulet™ LAA occluder can be performed with high procedural success and acceptable outcomes. 10.5935/abc.20190138
    Nonvalvular atrial fibrillation in high-hemorrhagic-risk patients: state of the art of percutaneous left atrial appendage occlusion. Merella Pierluigi,Lorenzoni Giovanni,Marziliano Nicola,Berne Paola,Viola Graziana,Pischedda Paolo,Casu Gavino Journal of cardiovascular medicine (Hagerstown, Md.) : Atrial fibrillation is the most common cardiac arrhythmia and its prevalence is constantly increasing. The main complications related to atrial fibrillation are death and major stroke. Oral anticoagulant therapy is the cornerstone of management of atrial fibrillation patients at increased stroke risk. Unfortunately, a significant proportion of patients do not receive adequate anticoagulant therapy due to increased or prohibitive hemorrhagic risk. The observation that most thrombi are generated in the left atrial appendage (LAA) had led to the consideration of surgical or percutaneous occlusion as an alternative. During recent years, the WATCHMAN percutaneous occlusion device has proven to be not inferior to anticoagulant therapy for the prevention of thromboembolic events, with the added benefit of a lower rate of hemorrhagic events. Numerous data showed the same results for the AMPLATZER cardiac plug and Amulet devices. Left atrial appendage occlusion (LAAO) often represents the only therapeutic strategy in this group of patients. We describe the current state of the art of percutaneous LAAO in atrial fibrillation patients with a high hemorrhagic risk. 10.2459/JCM.0000000000000735
    Left atrial appendage occlusion for stroke prevention in diabetes mellitus patients with atrial fibrillation: Long-term results. Litwinowicz Radoslaw,Bartus Magdalena,Ceranowicz Piotr,Brzezinski Maciej,Kapelak Bogusław,Lakkireddy Dhanunjaya,Bartus Krzysztof Journal of diabetes BACKGROUND:Concomitant diabetes mellitus (DM) in atrial fibrillation (AF) may increase the risk of thromboembolism. Left atrial appendage occlusion (LAAO) is an alternative treatment in AF patients in whom antithrombotic therapy is ineffective or contraindicated. The aim of this study was to evaluate the long-term efficacy of LAAO in DM patients with AF. METHODS:A retrospective study was conducted in 139 patients who had undergone LAAO and were categorized into two groups: 28 patients with DM and 111 patients without DM. Overall, the follow-up period was 530 patient-years. RESULTS:Mean CHADS and CHA DS -VASc scores were higher in patients with than without DM (2.6 vs 1.7 [P < 0.001] and 3.5 vs 2.8 [P = 0.056], respectively). There were no significant differences between the two groups in terms of HAS-BLED scores and other patient factors (sex, age, heart failure, hypertension, previous stroke or transient ischemic attack, peripheral vascular disease) that may increase the risk of thromboembolism based on CHA DS -VASc. The mean follow-up period was 51.6 and 50 months in patients with DM and without DM, respectively. Comparing patients with and without DM, there were no significant differences in thromboembolic events (4% vs 1.9%), severe bleeding (0% vs 3.1%), or mortality (4% vs 5.9%). The estimated reductions in thromboembolic and bleeding risk were 77% and 100%, respectively, for patients with DM, compared with 85% and 62%, respectively, for patients without DM. CONCLUSION:The present study indicates that LAAO in AF patients with DM has similar safety endpoints and long-term efficacy as LAAO in patients without DM. 10.1111/1753-0407.12824
    Over 1-year efficacy and safety of left atrial appendage occlusion versus novel oral anticoagulants for stroke prevention in atrial fibrillation: A systematic review and meta-analysis of randomized controlled trials and observational studies. Li Xin,Wen Song-Nan,Li Song-Nan,Bai Rong,Liu Nian,Feng Li,Ruan Yan-Fei,Du Xin,Dong Jian-Zeng,Ma Chang-Sheng Heart rhythm BACKGROUND:A direct comparison of the efficacy and safety profiles of left atrial appendage occlusion (LAAO) devices and novel oral anticoagulants (NOACs) for stroke prevention in atrial fibrillation is warranted but currently unavailable. OBJECTIVE:The aim of this study was to compare the >1-year efficacy and safety of LAAO devices and NOACs for stroke prevention in patients with atrial fibrillation. METHODS:We performed a systematic review on randomized controlled trials (RCTs) and observational studies. RCTs were analyzed by means of a network meta-analysis method using warfarin as a bridge to compare LAAO to individual NOAC or all NOACs as a whole. Observational studies were analyzed with the meta-proportion function where pooled event rates were compared. RESULTS:A total of 6 RCTs and 27 observational studies were included. A network meta-analysis of RCTs indicated that LAAO was less effective than NOACs for stroke prevention (odds ratio 0.86), but had a lower rate of hemorrhagic events during follow-up. However, a meta-proportion analysis of observational studies revealed that LAAO devices were associated with a lower rate of both thromboembolic events (1.8 events per 100 patient-years vs 2.4 events per 100 patient-years) and major bleeding events during follow-up (2.2 events per 100 patient-years vs 2.5 events per 100 patient-years) as compared with NOACs. With prolonged follow-up duration after LAAO implantation, the rate of thromboembolic events decreased (2.1, 1.8, and 1.0 events per 100 person-years for 1, 1-2, and >2 years, respectively). CONCLUSION:Although superiority of LAAO over NOACs was not demonstrated by RCTs in terms of stroke prevention, LAAO was found to be consistently associated with a lower rate of both thromboembolic and hemorrhagic events as compared with NOACs in observational studies. 10.1016/j.hrthm.2015.12.037
    Does left atrial appendage (LAA) occlusion device alter the echocardiography and electrocardiogram parameters in patients with atrial fibrillation? Jie Qiqiang,Wang Dongzhi,Liu Baoxin,Zhao Dongdong,Li Yong,Luo Jiachen,Dai Liming,Li Shuang,Xu Yawei,Wei Yidong International journal of cardiology BACKGROUND:The alterations of echocardiography and electrocardiogram (ECG) in patients received left atrial appendage LAA occlusion therapy are still unclear. The present study was to evaluate the influence of LAA occlusion device on echocardiography and ECG changes in patients with atrial fibrillation (AF). METHODS:Seventy-three patients who had undergone Watchman, LAmbre and Lefort were enrolled in this study. Echocardiography and ECG results at pre- and post-operation were collected. Besides, echocardiography was also performed during follow-up visits at 1, 6 and 12months after discharge. RESULTS:After LAA occlusion, a slight and measureable movement of QRS electric axis was observed in most patients. The significant differences were also observed in heart rate (HR) and the mean-mean QT interval between pre- and post-operation for all patients. There existed no significant difference in echocardiographic parameters between before and after device implantation. However, a larger left atrial (LA) diameter was detected by echocardiography during follow-up visit at 6months when compared with pre-operation parameters. Similarly, aortic root diameter (ARD) was also larger during follow-up at 12months than the baseline dimension in pre-operation. CONCLUSIONS:LAA occlusion device resulted in a slightly movement in QRS axis, reduced HR and increased the mean-mean QT interval duration. In addition, LA diameter and ARD seemed to be larger after device implantation. 10.1016/j.ijcard.2016.03.204
    Usefulness of N-terminal-pro B-type natriuretic peptide as a heart failure marker in patients undergoing percutaneous left atrial appendage occlusion. Streb Witold,Mitręga Katarzyna,Szymała Magdalena,Podolecki Tomasz,Kalarus Zbigniew Kardiologia polska BACKGROUND:The left atrial appendage is involved in secretion of N-terminal-pro B-type natriuretic peptide (NT-proBNP). Percutaneous left atrial appendage occlusion (LAAO) for prevention of stroke may cause variations in NT-proBNP release. AIM:This study aimed to assess the diagnostic value of NT-proBNP after LAAO. METHODS:The study group comprised 53 patients in whom LAAO was performed. The patients with heart failure (HF) and reduced ejection fraction (EF) were allocated to group I (n = 16) whereas patients with no HF symptoms and EF > 40% were allocated to group II (n = 37). The symptomatic patients with EF > 40% were excluded. NT-proBNP values were measured prior to LAAO, at one-two days, and at three-month follow-up. EF, six-minute walk test (6MWT), and peak oxygen consumption (VO2max) were assessed 24 h prior to LAAO and after three months. RESULTS:Prior to LAAO the NT-proBNP level was higher in group I, when compared to group II (3084.74 ± 559.53 pg/mL vs. 808.02 ± 115.83 pg/ml, p < 0.01). In both groups there was a nonsignificant increase in NT-proBNP level at one-two days after LAOO (3100.14 ± 690.08 pg/mL in group I and 1012.09 ± 166.71 pg/mL in group II). At the three-month follow-up a further increase of NT-proBNP level in group I (3852.73 ± 1025.78 pg/mL) and a decrease in group II (855.03 ± 107.49 pg/mL) was observed. The pairwise comparison between the means of 6MWT and VO2max showed no significant changes during follow-up. At baseline, NT-proBNP level of 988 pg/mL presented 87.5% sensitivity and 75.7% specificity for prediction of HF. Three months after LAAO, it increased to 1358 pg/mL (sensitivity 81.2%, specificity 78.4%). CONCLUSIONS:When diagnosing HF in atrial fibrillation patients, the higher cut-off value of NT-proBNP should be used. NT-proBNP remains an appropriate diagnostic marker of HF in patients after LAAO. 10.5603/KP.a2017.0185