Efficacy of an Adjunctive Electrophysiological Test–Guided Left Atrial Posterior Wall Isolation in Persistent Atrial Fibrillation Without a Left Atrial Low-Voltage Area

Background: Electrical remodeling precedes structural remodeling. In adjunctive left atrial (LA) low-voltage area (LVA) ablation to pulmonary vein isolation of atrial fibrillation (AF), LA areas without LVA have not been targeted for ablation. We studied the effect of adjunctive LA posterior wall isolation (PWI) on persistent AF without LA-LVA according to electrophysiological testing (EP test). Methods: We examined consecutive patients with persistent AF with (n=33) and without (n=111) LA-LVA. Patients without LA-LVA were randomly assigned to EP test–guided (n=57) and control (n=54) groups. In the EP test–guided group, an adjunctive PWI was performed in those with positive results (PWI subgroup; n=24), but not in those with negative results (n=33). The criteria for positive EP tests were an effective refractory period ≤180 ms, effective refractory period>20 ms shorter than the other sites, and/or induction of AF/atrial tachycardia (AT) during measurements. LVA ablation was performed in the patients with LA-LVA. Results: During the follow-up period (62±33 weeks), the EP test–guided group had significantly lower recurrence rates (19%,11/57 versus 41%, 22/54, P =0.012) and higher Kaplan-Meier AF/AT–free survival curve rates than the control group ( P =0.01). No significant differences in the recurrence and AF/AT–free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed. Therefore, PWI for positive EP tests reduced the AF/AT recurrence in the EP test–guided group. A stepwise Cox proportional hazard analyses identified EP test–guided ablation as a factor reducing the recurrence rate. The recurrence rates in the LA-LVA ablation group and EP test–guided group were similar. Conclusions: This pilot study proposed that an EP test–guided adjunctive PWI of persistent AF without LA-LVA potentially reduced AF/AT recurrences. The results suggest that there is an AF substrate in the LA with altered electrophysiological function even when there is no LA-LVA. Graphic Abstract: A graphic abstract is available for this article.

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Impact of Left Atrial Posterior Wall Isolation Technique on the Outcome of Ablation in Persistent Atrial Fibrillation

QJM ◽

10.1093/qjmed/hcab090.006 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Ahmed I Elbatran ◽

Mervat Abou- Elmaaty Nabih ◽

Magdi M Saba ◽

Rania Samir ◽

Mazen Tawfik ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Persistent Atrial Fibrillation ◽

Posterior Wall ◽

Atrial Tachyarrhythmia ◽

Isolation Technique ◽

Free Survival ◽

Procedural Complications ◽

One Year ◽

Left Atrial Posterior

Abstract Background Left atrial posterior wall (LAPW) isolation is an adjunct to pulmonary vein isolation (PVI) for persistent atrial fibrillation (AF). Objective To compare the effect of LAPW box isolation with LAPW point-by-point ablation and PVI in persistent AF on 12-month arrhythmia-free survival and procedure complications. Methods 77 consecutive patients who underwent LAPW box isolation, 24 patients who underwent LAPW point-by-point ablation and 101 patients who underwent PVI for persistent AF were compared. All patients had undergone no prior ablation for AF and were followed up for one year. Results Mean time to atrial tachyarrhythmia recurrence was similar with LAPW box isolation (9.8 months, 95% CI = 9-10.7) and LAPW point-by-point ablation (10 months, 95% CI = 8.6-11.3), both were longer than PVI (8.2 months, 95% CI = 7.4-9.1, log-rank p = 0.003). There was no difference in peri-procedural complications (LAPW box isolation: 5/77, LAPW point-by-point ablation: 1/24, PVI: 6/101, p = 0.91). At 12 months, no difference in atrial tachyarrhythmia recurrence was observed between box isolation (23/77, 30%) and point-bypoint ablation (11/24, 46%, p = 0.15), but significantly higher recurrence occurred with PVI alone (58/101, 57%, p < 0.001). Procedure time was similar with both approaches, with longer fluoroscopy with point-by-point ablation (median: 38 min, IQR: 29-47.75) vs box isolation (median: 28 min, IQR: 7.5-39.5, p = 0.2). Conclusion In persistent AF, there was no difference between LAPW box isolation and point-by-point ablation in terms of mean arrhythmia-free survival, 12-month recurrence or procedure complications. Arrhythmia-free survival with either technique was longer than PVI alone, with no increase in complications.

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Extra-pulmonary vein driver mapping and ablation for persistent atrial fibrillation in obese patients

EP Europace ◽

10.1093/europace/euaa314 ◽

2020 ◽

Author(s):

Xiaofeng Hu ◽

Weifeng Jiang ◽

Shaohui Wu ◽

Kai Xu ◽

Daoliang Zhang ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Cardiac Computed Tomography ◽

Persistent Atrial Fibrillation ◽

Posterior Wall ◽

Obese Group ◽

Rank Test ◽

Obese Patients ◽

Free Survival ◽

Log Rank Test

Abstract Aims The aim of this study was to determine whether driver ablation effectively treats persistent atrial fibrillation (AF) in obese patients. Methods and results We randomly assigned 124 persistent AF obese patients to two groups, one undergoing conventional ablation (n = 62) and the other undergoing driver ablation (n = 62). Sixty-two non-obese patients with persistent AF undergoing driver ablation served as matched controls. Bipolar electrogram dispersion was analysed for driver mapping. Epicardial adipose tissue (EAT) volume was measured using cardiac computed tomography. Obese patients had a higher proportion of driver regions in the posterior wall (56.5% vs. 32.3%, P = 0.007). Driver complexity, measured as the average number and area of driver regions, was higher in the obese group than in the non-obese group (3.5 ± 1.0 vs. 2.9 ± 0.9, P < 0.001; 15.5% ± 4.2% vs. 9.8 ± 2.6%, P < 0.001, respectively). Left atrial EAT volume correlated better with the proportion of area of driver regions than did body mass index (BMI) and total EAT (BMI: r2 = 0.250, P < 0.001; total EAT: r2 = 0.379, P < 0.001; and left atrial EAT: r2 = 0.439, P < 0.001). The rate of AF termination was significantly higher in the driver ablation group than in the conventional ablation group (82.9% vs. 22.8%, P < 0.001). During the follow-up period of 16.9 ± 6.5 months, patients in the driver ablation group had significantly better AF-free survival (91.91% vs. 79.0%, log rank test, P = 0.026) and AF/atrial tachycardia-free survival (83.9% vs. 64.5%, log rank test, P = 0.011) than did patients in the conventional ablation group. Conclusion Obesity is associated with increased driver complexity. Driver ablation improves long-term outcomes in obese patients with persistent AF.

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Spatial and quantitative assessment of the correlation between sinus rhythm and atrial fibrillation voltage mapping to identify low voltage substrate in persistent atrial fibrillation

EP Europace ◽

10.1093/europace/euab116.163 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

D Nairn ◽

C Nagel ◽

B Mueller-Edenborn ◽

H Lehrmann ◽

A Jadidi ◽

...

Keyword(s):

Atrial Fibrillation ◽

Sinus Rhythm ◽

Left Atrial ◽

Low Voltage ◽

Persistent Atrial Fibrillation ◽

Posterior Wall ◽

Shape Modelling ◽

National Budget ◽

Spatial Concordance ◽

Public Grant

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Deutsche Forschungsgemeinschaft (DFG) through DO637/22-3 Ministerium für Wissenschaft, Forschung und Kunst Baden-Württemberg through the Research Seed Capital (RiSC) program. Introduction Presence of left atrial (LA) fibrotic low voltage substrate (LVS) is associated with high risk for arrhythmia recurrences in patients undergoing pulmonary vein isolation (PVI) for atrial fibrillation (AF). PVI and additional ablation of LVS - as identified by mapping in sinus rhythm (SR) or AF - has been reported to improve SR maintenance rates, despite differences of the extent and distribution of LA-LVS in SR versus AF. Aims To study the relationship between SR and AF voltage maps, we sought to identify the optimal AF voltage threshold providing the highest concordance in the extent and distribution of LVS when comparing voltage maps in SR vs. AF. Methods Using the statistical shape modelling software Scalismo, the voltage information from the SR and AF maps (acquired prior to PVI) from 28 patients (66 ± 7 years, 46% male, 82% persistent AF) was projected onto a representative LA-geometry. Sensitivity and specificity of LVS identification were calculated for varying thresholds during AF and the correlation between the SR (threshold 0.5mV) and AF maps was assessed and areas of agreeing LVS classification (SR & AF) were identified for each patient. The data of all 28 patients were combined to a spatial histogram of agreement between SR and AF low voltage maps. Results The correlation between SR and AF maps was high across all patients, with agreement at 60-95% of all mapped sites (Figure A: each red triangle represents one patient and the respective agreement of LVS classification and substrate extent). The optimal AF threshold - to identify LA-LVS <0.5 mV in SR - was 0.29 mV (Q1-3: 0.20-0.37 mV) and was independent of the underlying extent of LVS during SR (Figure A: each blue asterisk represents one patient and the corresponding AF threshold and substrate extent). Agreement between LVS in AF vs. SR was high across most (>90) patients on the anterior LA, lateral LA and the left atrial appendage. Lower agreement (60% of patients) was observed in the posterior wall (Figure B). Conclusions SR and AF voltage maps reveal high spatial concordance in low voltage substrate at the anterior LA, lateral LA and LA appendage, however significant discordances in LVS are found in 40% of patients at the posterior LA. Further studies on an extended patient cohort should assess if regional voltage-thresholds would result in an improved substrate concordance between AF and SR substrate maps. Abstract Figure.

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Left Atrial Hypertension, Electrical Conduction Slowing, and Mechanical Dysfunction – The Pathophysiological Triad in Atrial Fibrillation-Associated Atrial Cardiomyopathy

Frontiers in Physiology ◽

10.3389/fphys.2021.670527 ◽

2021 ◽

Vol 12 ◽

Author(s):

Martin Eichenlaub ◽

Bjoern Mueller-Edenborn ◽

Jan Minners ◽

Nikolaus Jander ◽

Martin Allgeier ◽

...

Keyword(s):

Atrial Fibrillation ◽

Electrical Conduction ◽

Left Atrial ◽

Low Voltage ◽

Maximum Amplitude ◽

P Wave ◽

Recurrence Rates ◽

Left Atrial Strain ◽

2D Echocardiography ◽

Surface Ecg

BackgroundAtrial fibrillation (AF) is the most common arrhythmia and a significant burden for healthcare systems worldwide. Presence of relevant atrial cardiomyopathy (ACM) is related to persistent AF and increased arrhythmia recurrence rates after pulmonary vein isolation (PVI).ObjectiveTo investigate the association of left atrial pressure (LAP), left atrial electrical [invasive atrial activation time (IAAT) and amplified p-wave duration (aPWD)] and mechanical [left atrial emptying fraction (LA-EF) and left atrial strain (LAS)] functional parameters with the extent of ACM and their impact on arrhythmia recurrence following PVI.Materials and MethodsFifty patients [age 67 (IQR: 61–75) years, 78% male] undergoing their first PVI for persistent AF were prospectively included. LAP (maximum amplitude of the v-wave), digital 12-lead electrocardiogram, echocardiography and high-density endocardial contact mapping were acquired in sinus rhythm prior to PVI. Arrhythmia recurrence was assessed using 72-hour Holter electrocardiogram at 6 and 12 months post PVI.ResultsRelevant ACM (defined as left atrial low-voltage extent ≥2 cm2 at <0.5 mV threshold) was diagnosed in 25/50 (50%) patients. Compared to patients without ACM, patients with ACM had higher LAP [17.6 (10.6–19.5) mmHg with ACM versus 11.3 (7.9–14.0) mmHg without ACM (p = 0.009)]. The corresponding values for the electrical parameters were 166 (149–181) ms versus 139 (131–143) ms for IAAT (p < 0.0001), 163 (154–176) ms versus 148 (136–152) ms for aPWD on surface-ECG (p < 0.0001) and for the mechanical parameters 27.0 (17.5–37.0) % versus 41.0 (35.0–45.0) % for LA-EF in standard 2D-echocardiography (p < 0.0001) and 15.2 (11.0–21.2) % versus 29.4 (24.9–36.6) % for LAS during reservoir phase (p < 0.0001). Furthermore, all parameters showed a linear correlation with ACM extent (p < 0.05 for all). Receiver-operator-curve-analysis demonstrated a LAP ≥12.4 mmHg [area under the curve (AUC): 0.717, sensitivity: 72%, and specificity: 60%], a prolonged IAAT ≥143 ms (AUC: 0.899, sensitivity: 84%, and specificity: 80%), a prolonged aPWD ≥153 ms (AUC: 0.860, sensitivity: 80%, and specificity: 79%), an impaired LA-EF ≤33% (AUC: 0.869, sensitivity: 84%, and specificity: 72%), and an impaired LAS during reservoir phase ≤23% (AUC: 0.884, sensitivity: 84%, and specificity: 84%) as predictors for relevant ACM. Arrhythmia recurrence within 12 months post PVI was significantly increased in patients with relevant ACM ≥2 cm2, electrical dysfunction with prolonged IAAT ≥143 ms and mechanical dysfunction with impaired LA-EF ≤33% (66 versus 20, 50 versus 23 and 55 versus 25%, all p < 0.05).ConclusionLeft atrial hypertension, electrical conduction slowing and mechanical dysfunction are associated with ACM. These findings improve the understanding of ACM pathophysiology and may be suitable for risk stratification for new-onset AF, arrhythmia recurrence following PVI, and development of novel therapeutic strategies to prevent AF and its associated complications.

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Canagliflozin Suppresses Atrial Remodeling in a Canine Atrial Fibrillation Model

Journal of the American Heart Association ◽

10.1161/jaha.119.017483 ◽

2021 ◽

Author(s):

Ryo Nishinarita ◽

Shinichi Niwano ◽

Hiroe Niwano ◽

Hironori Nakamura ◽

Daiki Saito ◽

...

Keyword(s):

Atrial Fibrillation ◽

Conduction Velocity ◽

Refractory Period ◽

Interstitial Fibrosis ◽

Sglt2 Inhibitor ◽

Effective Refractory Period ◽

Control Group ◽

Atrial Remodeling ◽

Atrial Pacing ◽

Atrial Effective Refractory Period

Background Recent clinical trials have demonstrated the possible pleiotropic effects of SGLT2 (sodium–glucose cotransporter 2) inhibitors in clinical cardiovascular diseases. Atrial electrical and structural remodeling is important as an atrial fibrillation (AF) substrate. Methods and Results The present study assessed the effect of canagliflozin (CAN), an SGLT2 inhibitor, on atrial remodeling in a canine AF model. The study included 12 beagle dogs, with 10 receiving continuous rapid atrial pacing and 2 acting as the nonpacing group. The 10 dogs that received continuous rapid atrial pacing for 3 weeks were subdivided as follows: pacing control group (n=5) and pacing+CAN (3 mg/kg per day) group (n=5). The atrial effective refractory period, conduction velocity, and AF inducibility were evaluated weekly through atrial epicardial wires. After the protocol, atrial tissues were sampled for histological examination. The degree of reactive oxygen species expression was evaluated by dihydroethidium staining. The atrial effective refractory period reduction was smaller ( P =0.06) and the degree of conduction velocity decrease was smaller in the pacing+CAN group compared with the pacing control group ( P =0.009). The AF inducibility gradually increased in the pacing control group, but such an increase was suppressed in the pacing+CAN group ( P =0.011). The pacing control group exhibited interstitial fibrosis and enhanced oxidative stress, which were suppressed in the pacing+CAN group. Conclusions CAN and possibly other SGLT2 inhibitors might be useful for preventing AF and suppressing the promotion of atrial remodeling as an AF substrate.

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Classification of Left Atrial Diseased Tissue Burden Determined by Automated Voltage Analysis Predicts Outcomes after Ablation for Atrial Fibrillation

Disease Markers ◽

10.1155/2021/5511267 ◽

2021 ◽

Vol 2021 ◽

pp. 1-8

Author(s):

Szilvia Herczeg ◽

John J. Keaney ◽

Edward Keelan ◽

Claire Howard ◽

Katie Walsh ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Low Voltage ◽

Electroanatomical Mapping ◽

Success Rates ◽

High Definition ◽

Recurrence Rates ◽

Class Iv

Background. The burden and persistence of atrial fibrillation (AF) have been associated with the presence and extent of left atrial (LA) fibrosis. Recent reports have implicated an association between the extent of LA fibrosis and the outcome of pulmonary vein isolation (PVI). We aimed to analyse the value of an automated scar quantification method in the prediction of success following PVI. Methods. One hundred and nine consecutive patients undergoing PVI for paroxysmal or persistent AF were included in our observational study with a 2-year follow-up. Prior to PVI, patients underwent high-definition LA electroanatomical mapping, and scar burden was quantified by automated software (Voltage Histogram Analysis, CARTO 3, Biosense Webster), then classified into 4 subgroups (Dublin Classes I-IV). Recurrence rates were analysed on and off antiarrhythmic drug therapy (AAD), respectively. Results. The overall success rate was 74% and 67% off AAD at 1- and 2-year follow-up, respectively. Patients with Dublin Class IV had significantly lower success rates ( p = 0.008 , off AAD). Dublin Class IV ( OR = 2.27 , p = 0.022 , off AAD) and the presence of arrhythmia in the blanking period ( OR = 3.28 , p = 0.001 , off AAD) were the only significant predictors of recurrence. The use of AAD did not affect these results. Conclusions. We propose a classification of low voltage areas based on automated quantification by software during 3D mapping prior to PVI. Patients with high burden of low voltage areas (>31% of <0.5 mV, Dublin Class IV) have a higher risk of recurrence following PVI. Information gathered during electroanatomical mapping may have important prognostic value.

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The impact of an empiric superior vena cava isolation added to pulmonary vein isolation for non-paroxysmal atrial fibrillation associated with left atrial low voltage areas

European Heart Journal ◽

10.1093/ehjci/ehaa946.0578 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T Omuro ◽

Y Yoshiga ◽

M Fukuda ◽

T Kato ◽

S Fujii ◽

...

Keyword(s):

Atrial Fibrillation ◽

Pulmonary Vein ◽

Superior Vena Cava ◽

Left Atrial ◽

Low Voltage ◽

Superior Vena ◽

Vena Cava ◽

Free Survival ◽

Initial Session ◽

The Impact

Abstract Introduction Left atrial low-voltage areas (LVAs) are associated with recurrence after radiofrequency catheter ablation of atrial fibrillation (AF). However, the impact of LVAs on recurrence after an empiric pulmonary vein isolation (PVI) plus superior vena cava isolation (SVCI) strategy for non-Paroxysmal AF (PAF) patients remains unclear. Purpose We evaluated the impact of LVAs on the recurrence of atrial tachyarrhythmias (ATs)/AF in patients who underwent an empiric SVCI added to the PVI for non-PAF. Methods We enrolled 153 consecutive patients with non-PAF who underwent a PVI alone (PVI group; n=51) or empiric PVI plus SVCI (PVI+SVCI group; n=102). Left atrial voltage maps were constructed during sinus rhythm to identify the LVAs (<0.5 mV). No patients underwent a substrate modification of the LVAs. We divided the patients into two groups based on the LVAs (with or without an LVA >5% of the left atrial surface area) and investigated the ATs/AF free survival rate after the initial and multiple procedures. Results LVAs were identified in 65% and 73% of the PVI and PVI + SVCI groups, respectively (P=0.319). In the PVI group, the 18-month ATs/AF-free survival was 61% of the patients without LVAs and 27% of patients with LVAs after the initial session (P=0.018) (Figure 1-A). Seventy-two percent of the patients without LVAs and 46% of those with LVAs were free from ATs/AF after multiple sessions (P=0.083) (Figure 1-B). In the PVI+SVCI group, 50% of the patients with LVAs and 61% of those without LVAs had no recurrence after the initial session (P=0.374) (Figure 2-A). Moreover, there was no significant difference in the 18-month ATs/AF-free survival between the patients with and without LVAs after multiple sessions (73% vs. 79%; P=0.520) (Figure 2-B). Conclusion A PVI alone strategy for non-PAF patients with LVAs had limited efficacy for the outcomes, even with multiple procedures. However, an SVCI may have the potential to compensate for an impaired outcome in patients with LVAs. Funding Acknowledgement Type of funding source: None

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Relationship between left atrial strain and left atrial bipolar voltage in patients undergoing catheter ablation for atrial fibrillation

European Heart Journal ◽

10.1093/ehjci/ehaa946.0387 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

Y Takahashi ◽

T Kitai ◽

T Watanabe ◽

T Fujita

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Speckle Tracking ◽

Longitudinal Strain ◽

Low Voltage ◽

Pulmonary Veins ◽

Global Longitudinal Strain ◽

Inferior Wall ◽

Bipolar Voltage ◽

Global Mean

Abstract Background Low-voltage zone (LVZ) in the left atrium (LA) seems to represent fibrosis. LA longitudinal strain assessed by speckle tracking method is known to correlate with the extent of fibrosis in patients with mitral valve disease. Purpose We sought to identify the relationship between LA longitudinal strain and LA bipolar voltage in patients with atrial fibrillation (AF). We tested the hypothesis that LA strain can predict LA bipolar voltage. Methods A total of 96 consecutive patients undergoing initial AF ablation were analyzed. All patients underwent transthoracic echocardiography including 2D speckle tracking measurement on the day before ablation during sinus rhythm (SR group, N=54) or during AF (AF group, N=42). LA longitudinal strain was measured at basal, mid, and roof level of septal, lateral, anterior, and inferior wall in apical 4- and 2-chamber view. Global longitudinal strain (GLS) was defined as an average value of the 12 segments. LA voltage map was created using EnSite system, and global mean voltage was defined as a mean of bipolar voltage of the whole LA excluding pulmonary veins and left atrial appendage. LVZ was defined as less than 1.0 mV. Results There was a significantly positive correlation between GLS and global mean voltage (r=0.708, p<0.001). Multivariate regression analysis showed that GLS and age were independent predictors of global mean voltage. There was a significant negative correlation between global mean voltage and LVZ areas. Conclusions There was a strong correlation between LA longitudinal strain and LA mean voltage. GLS can independently predict LA mean voltage, subsequently LVZ areas in patients with AF. Funding Acknowledgement Type of funding source: None

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Persistent Atrial Fibrillation: The Role of Left Atrial Posterior Wall Isolation and Ablation Strategies

Journal of Clinical Medicine ◽

10.3390/jcm10143129 ◽

2021 ◽

Vol 10 (14) ◽

pp. 3129

Author(s):

Riyaz A. Kaba ◽

Aziz Momin ◽

John Camm

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Pulmonary Veins ◽

Treatment Strategies ◽

Persistent Atrial Fibrillation ◽

Posterior Wall ◽

Cardiovascular Death ◽

Good Effect ◽

Complex Forms

Atrial fibrillation (AF) is a global disease with rapidly rising incidence and prevalence. It is associated with a higher risk of stroke, dementia, cognitive decline, sudden and cardiovascular death, heart failure and impairment in quality of life. The disease is a major burden on the healthcare system. Paroxysmal AF is typically managed with medications or endocardial catheter ablation to good effect. However, a large proportion of patients with AF have persistent or long-standing persistent AF, which are more complex forms of the condition and thus more difficult to treat. This is in part due to the progressive electro-anatomical changes that occur with AF persistence and the spread of arrhythmogenic triggers and substrates outside of the pulmonary veins. The posterior wall of the left atrium is a common site for these changes and has become a target of ablation strategies to treat these more resistant forms of AF. In this review, we discuss the role of the posterior left atrial wall in persistent and long-standing persistent AF, the limitations of current endocardial-focused treatment strategies, and future perspectives on hybrid epicardial–endocardial approaches to posterior wall isolation or ablation.

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Double-blind, placebo-controlled randomised clinical trial to evaluate the effect of ASPIRIN discontinuation after left atrial appendage occlusion in atrial fibrillation: protocol of the ASPIRIN LAAO trial

BMJ Open ◽

10.1136/bmjopen-2020-044695 ◽

2021 ◽

Vol 11 (3) ◽

pp. e044695

Author(s):

Mu Chen ◽

Qunshan Wang ◽

Jian Sun ◽

Peng-Pai Zhang ◽

Wei Li ◽

...

Keyword(s):

Atrial Fibrillation ◽

Left Atrial ◽

Left Atrial Appendage ◽

Ethics Committee ◽

Aspirin Therapy ◽

Atrial Appendage ◽

Control Group ◽

Coronary Syndrome ◽

Left Atrial Appendage Occlusion ◽

Increased Risk

IntroductionIt is the common clinical practice to prescribe indefinite aspirin for patients with non-valvular atrial fibrillation (NVAF) post left atrial appendage occlusion (LAAO). However, aspirin as a primary prevention strategy for cardiovascular diseases has recently been challenged due to increased risk of bleeding. Therefore, aspirin discontinuation after LAAO in atrial fibrillation (ASPIRIN LAAO) trial is designed to assess the uncertainty about the risks and benefits of discontinuing aspirin therapy at 6 months postimplantation with a Watchman LAAO device in NVAF patients.Methods and analysisThe ASPIRIN LAAO study is a prospective, multicentre, randomised, double-blinded, placebo-controlled non-inferiority trial. Patients implanted with a Watchman device within 6 months prior to enrollment and without pre-existing conditions requiring long-term aspirin therapy according to current guidelines are eligible for participating the trial. Subjects will be randomised in a 1:1 allocation ratio to either the Aspirin group (aspirin 100 mg/day) or the control group (placebo) at 6 months postimplantation. A total of 1120 subjects will be enrolled from 12 investigational sites in China. The primary composite endpoint is stroke, systemic embolism, cardiovascular/unexplained death, major bleeding, acute coronary syndrome and coronary or periphery artery disease requiring revascularisation at 24 months. Follow-up visits are scheduled at 6 and 12 months and then every 12 months until 24 months after the last patient recruitment.Ethics and disseminationEthics approval was obtained from the Ethics Committee of Xinhua Hospital, Shanghai, China (reference number XHEC-C-2018-065-5). The protocol is also submitted and approved by the institutional Ethics Committee at each participating centre. Results are expected in 2024 and will be disseminated through peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT03821883.

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