Summary
Background
After left atrial appendage closure (LAAC), various antithrombotic protocols have been suggested, but the optimal post-procedural antithrombotic strategy is still under debate.
Aims
To investigate the efficacy and safety of LAAC with an AMPLATZER™ Cardiac Plug (ACP) device (St. Jude Medical, Minneapolis, MN, USA) followed by single antiplatelet therapy.
Methods
Consecutive patients with non-valvular atrial fibrillation and a contraindication for oral anticoagulants who underwent LAAC with an ACP device between 2012 and 2014 in two French centres were included. Follow-up included clinical evaluation at 1, 3, 6 and 12 months, and yearly thereafter, and a cardiac computed tomography scan at 3 months to assess device position, device-related thrombus and residual leak. Single antiplatelet therapy was prescribed after the procedure for at least 12 months.
Results
A total of 76 patients underwent successful LAAC (mean age: 73 years; 59% men; mean CHA 2 DS 2 -VASc score 4.4 ± 1.3; mean HAS-BLED score 3.4 ± 0.9). Three major complications occurred during the periprocedural period (one cardiac tamponade and two access site haematomas). Device thrombosis was observed at 3 months in five (6.8%) patients who remained asymptomatic. After a mean follow-up of 13 months, the rates of death, stroke and major bleeding were 2.6%, 4.0% and 1.3%, respectively. Embolic and bleeding events were less frequent than expected from CHA 2 DS 2 -VASc (4.0% vs 9.9%; P < 0.001) and HAS-BLED (1.3% vs 4.3%; P < 0.001) risk scores.
Conclusions
LAAC using an ACP device followed by single antiplatelet therapy could be a reasonable alternative for stroke prevention.
Résumé
Contexte
Après la fermeture percutanée de l’auricule gauche (FPAG), plusieurs protocoles antithrombotiques ont été suggérés mais la stratégie optimale de traitement antithrombotique reste débattue.
Objectifs
Évaluer l’efficacité et l’innocuité de la FPAG avec les dispositifs Amplatzer Cardiac Plug (St. Jude Medical, Minneapolis, Minnesota) (ACP) suivie d’une monothérapie antiagrégante plaquettaire.
Méthodes
Les patients consécutifs ayant une fibrillation atriale non-valvulaire et une contre-indication aux anticoagulants oraux et ayant bénéficié d’une FPAG avec un dispositif ACP entre 2012 et 2014 dans 2 centres français étaient inclus. Le suivi comportait une évaluation clinique à 1, 3, 6 et 12 mois, puis de manière annuelle ainsi qu’une tomodensitométrie cardiaque à 3 mois pour évaluer la position de la prothèse, la présence d’un éventuel thrombus ou une fuite résiduelle. Une monothérapie antiagrégante était prescrite après la procédure pour au moins 12 mois.
Résultats
Au total, 76 patients ont bénéficié une d’FPAG avec succès (âge : 73 ans, 59 % d’hommes, CHA 2 DS 2 -VASc score moyen 4,4 ± 1,3, HAS-BLED score moyen 3,4 ± 0,9). Trois complications majeures sont survenues durant la période periprocédurale (1 tamponnade et 2 complications hémorragiques au point de ponction). Un thrombus sur le dispositif était observé à 3 mois chez 5 patients (6,8 %) par ailleurs asymptomatiques. Après un suivi moyen de 13 mois, les taux de décès, d’accidents emboliques et hémorragiques étaient de 2,6 %, 4,0 % et 1,3 %, respectivement. Les évènements emboliques et hémorragiques étaient moins fréquents que le prédisaient les scores de CHA 2 DS 2 -VASc (4,0 % vs 9,9 % ; p < 0,001) et HAS-BLED (1,3 % vs 4,3 % ; p < 0,001).
Conclusions
La fermeture percutanée de l’auricule gauche avec les dispositifs ACP suivie d’une monothérapie antiagrégante peut constituer une alternative raisonnable pour la prévention des accidents emboliques.
Background
Atrial fibrillation (AF) is the most common sustained arrhythmia, and increases the risk of ischaemic stroke . Although oral anticoagulation (OAC) is recommended in patients with a CHA 2 DS 2 -VASc (cardiac failure, hypertension, age ≥ 75 [Doubled], Diabetes, Stroke [Doubled] – Vascular disease, age 65–74 and sex category [Female]) score ≥ 1, this medication is associated with severe haemorrhagic complications, and a large proportion of patients discontinue OAC after treatment initiation . The PROTECT AF trial showed that percutaneous left atrial appendage closure (LAAC) with the WATCHMAN™ device (Boston Scientific, Natick, MA, USA) was non-inferior, but also superior, to warfarin in preventing the combined outcome of stroke, systemic embolism and cardiovascular death . Published results of multicentre studies with the AMPLATZER™ Cardiac Plug (ACP) device (St. Jude Medical, Minneapolis, MN, USA) showed that the annualized rates of major bleeding and stroke were less frequent after LAAC than expected from the CHA 2 DS 2 -VASc and HAS-BLED (hypertension, abnormal liver/renal function, stroke, bleeding, labile international normalized ratio, elderly [age > 65 years], drugs/alcohol) scores . Therefore, LAAC has become an integral part of treatment guidelines in AF patients (grade IIb, level B) .
Post-procedural management of antithrombotic therapy in these patients remains, however, a challenge, as the bleeding risk needs to be balanced against the risk of thrombus formation on the device and thromboembolic complications . After LAAC, various antithrombotic protocols have been proposed by different teams, but the optimal postprocedural antithrombotic medication and its duration are still under debate (whether with the WATCHMAN™ device or the ACP device). In the PROTECT AF trial, warfarin was prescribed for the first 45 days, followed by dual antiplatelet therapy (DAPT) between 45 days and 6 months after implantation, and aspirin indefinitely . Other antithrombotic protocols included DAPT for 3 months, followed by a further 3 months with aspirin alone , or DAPT for only 6 weeks, followed by lifelong aspirin treatment . In the ASAP study, DAPT was administered for 6 months, followed by lifelong aspirin . In clinical practice, the anticoagulation protocol of the PROTECT AF trial (OAC for 6 weeks, DAPT for 6 months and lifelong aspirin) is recommended in the WATCHMAN™ device instructions for use. After ACP device implantation, an antiplatelet agent (aspirin or clopidogrel) is recommended for at least 6 months.
The aim of this prospective registry was to investigate the efficacy and safety of LAAC using an ACP device, followed by a lightened antithrombotic protocol, including single antiplatelet therapy.
Methods
This prospective registry included consecutive patients with non-valvular AF who underwent LAAC in two French centres (university hospital of Bordeaux and Pasteur Clinic, Toulouse) between January 2012 and December 2014. During this period, LAAC was performed in 76 patients using ACP devices, and in eight patients using WATCHMAN™ occluders. Therefore, to have a homogeneous population, and to avoid bias resulting from the small proportion of WATCHMAN™ patients, we decided to exclude them from the analysis and focus on the results with ACP devices.
Data were collected prospectively from each centre. Inclusion criteria were age > 18 years, documented non-valvular AF and one or more of the following conditions: severe bleeding or history of disease that contraindicates OAC therapy; repeated failure to adequately control international normalized ratio; high risk of falls. The definitive contraindication for anticoagulation was discussed for each patient during a monthly multidisciplinary meeting. The study protocol conformed with the ethical guidelines of the 1975 Declaration of Helsinki, and was approved by the ethics committees of contributing hospitals. All patients gave informed consent before procedures.
Device implantation
The LAAC procedure and the specific features of the ACP devices have been described in detail . All procedures were performed under general anaesthesia and femoral venous access. Real-time three-dimensional transoesophageal echocardiography (TOE) guidance was performed to determine left trial appendage (LAA) size (mm) and to rule out the presence of LAA thrombi. Patients received up to 100 IU/kg of unfractionated heparin intravenously to achieve an activated clotting time of > 250 seconds. After transseptal puncture, the LAA was engaged, and angiography was performed to define the LAA anatomy in standard angulations. The appropriate device size was then chosen according to the manufacturer’s recommendations. Appropriate device positioning and stability was assessed by TOE and fluoroscopy before releasing each device. Procedural success was defined as successful implantation of the device in the LAA with no residual leak > 3 mm on a colour Doppler ultrasound scan.
Antithrombotic therapy
No anticoagulation therapy was administered after the procedure. Single antiplatelet therapy, consisting of aspirin (80–325 mg/day) or clopidogrel (75 mg/day) alone, was started on the first day, and was given for at least 12 months after the procedure. Lifelong aspirin was given thereafter, in case of high cardiovascular risk, defined by: 10-year risk of fatal cardiovascular disease > 5% and/or diabetes mellitus and/or vascular disease (coronary artery disease, obliterative peripheral arteriopathy). This institutional antithrombotic protocol was chosen before initiating the LAAC programme, because a large majority of patients had an OAC contraindication with an increased risk of bleeding and, therefore, in cooperation with neurological and gastroenterology teams, we did not want to treat them with DAPT or OAC to decrease their haemorrhagic risk. In some cases, the choice and duration of single antiplatelet therapy were individualized depending on patient history and physician preference.
As there was no control group in this study, the efficacy of this antithrombotic strategy was evaluated by comparing the actual rate of embolic and bleeding events at follow-up with the event rate predicted by the patients’ CHA 2 DS 2 -VASc and HAS-BLED scores, respectively .
Follow-up
Transthoracic echocardiography (TTE) was performed 24 hours after the procedure in all patients. Follow-up was performed via clinical visits at 1, 3, 6 and 12 months, and yearly thereafter. TTE was performed at 1 month to evaluate device position. Control cardiac computed tomography (CT) was performed at 3 months to evaluate device position and device-related thrombi, and to assess residual peridevice leak. In case of an abnormal CT scan, TOE was performed to confirm the suspected diagnosis (i.e. thrombus or device-related leak). If device-related thrombus was confirmed, subcutaneous low-molecular-weight heparin at a therapeutic dose or a second antiplatelet agent was considered, depending on the patient’s individual bleeding risk.
Adverse events
Major complications occurring during the periprocedural and follow-up periods were defined according to valve academic research consortium-2 criteria , and included death, stroke, transient ischaemic attack (TIA), myocardial infarction, systemic embolization, device embolization, significant pericardial effusion or cardiac tamponade, major bleeding (requiring surgery or transfusion) and device-related complications requiring surgery.
Minor complications were defined as minor bleeding or vascular complications without the need for intervention.
Statistical analysis
Values are expressed as mean ± standard deviation or median [range] for continuous variables, and as numbers and percentages for categorical variables. The expected incidence of thromboembolic or bleeding events in the studied population was calculated as the mean of the individual risk of each patient, according to their CHA 2 DS 2 -VASc and HAS-BLED scores . The observed incidence of events was calculated per patient and year of follow-up (number of patients multiplied by the mean time of follow-up of those patients expressed in years). Comparisons between observed and expected rates of thromboembolic and bleeding events were assessed using binomial tests. A P -value < 0.05 was considered significant. Data analysis was performed using STATA ® software, (StataCorp LP, College Station, TX, USA).
Results
Population characteristics
A total of 76 patients were prospectively included in this study (mean age 73 ± 8 years; 59% men). Permanent AF was present in 42 (55%) patients. The mean CHA 2 DS 2 -VASc score was 4.4 ± 1.3. The mean HAS-BLED score was 3.4 ± 0.9, with a score ≥ 3 present in 66 (87%) patients. The main indication for LAAC was OAC contraindication (86%), mostly because of a neurological complication (66%). Baseline characteristics of the study population and LAAC indications are shown in Table 1 and Table 2 , respectively.
| Age (years) | 73 ± 8 |
| Men | 45 (59) |
| Atrial fibrillation | |
| Paroxysmal/persistent | 34 (45) |
| Permanent | 42 (55) |
| Congestive heart failure | 4 (5.4) |
| Arterial hypertension | 70 (93) |
| Diabetes mellitus | 24 (32) |
| Coronaropathy/peripheral vascular disease | 27 (36) |
| Previous stroke/TIA | 39 (52) |
| CHA 2 DS 2 -VASc score | 4.4 ± 1.3 |
| HAS-BLED score | 3.4 ± 0.9 |
| Annual risk of thromboembolism (%) | 9.9 ± 4.2 |
| Annual risk of major bleeding (%) | 4.3 ± 2.5 |
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