Summary
Background
Percutaneous left atrial appendage (LAA) closure has emerged as an alternative therapeutic option for the prevention of embolic stroke in high-risk patients with non-valvular atrial fibrillation. The presence of thrombus in the LAA is currently a contraindication to the procedure.
Aim
To describe a modified LAA closure technique that allows a safe procedure in patients with LAA thrombus.
Methods
Between May 2013 and October 2014, LAA closure was performed in three patients with LAA thrombus (mean age 73.6 ± 14 years; two men), using a modified technique that avoids manipulation of catheters or angiography in the LAA.
Results
Two patients had persistent thrombus despite appropriate antithrombotic therapy, while the other patient had a contraindication to systemic anticoagulation. The procedure was successful using the modified implantation technique in all patients. The implanted device was the AMPLATZER™ Cardiac Plug (St. Jude Medical, Minneapolis, MN, USA) in one patient and the Amulet™ (St. Jude Medical, Minneapolis, MN, USA) in two patients. No periprocedural complications occurred. After a mean follow-up of 8 ± 2 months, no deaths or late complications were observed.
Conclusions
Thrombus trapping is a feasible and effective technique for performing LAA occlusion in patients with thrombus within the LAA. This modification of the implantation technique may allow LAA closure indications to be extended to include patients with LAA thrombus, who were formerly considered unsuitable.
Résumé
Contexte
La fermeture percutanée de l’auricule gauche a émergé comme une alternative pour la prévention des accidents emboliques chez les patients à haut risque en fibrillation atriale non-valvulaire. La présence d’un thrombus demeure pour l’instant une contre-indication à cette procédure.
Objectifs
Décrire une technique modifiée de fermeture percutanée de l’auricule gauche permettant une procédure sécurisée chez les patients avec thrombus au sein de l’auricule.
Méthodes
Entre mai 2013 et octobre 2014, une fermeture percutanée de l’auricule gauche a été effectuée chez 3 patients (âge 73,6 ± 14 ans ; 2/3 hommes) présentant un thrombus au sein de l’auricule gauche en utilisant une technique d’implantation modifiée permettant d’éviter les manipulations de cathéters et les angiographies au sein de l’appendice.
Résultats
Deux patients avaient un thrombus appendiculaire persistant malgré un traitement antithrombotique approprié tandis que le patient restant présentait une contre-indication au traitement anticoagulant. La procédure modifiée s’est déroulée avec succès chez tous les patients. Le dispositif implanté était AMPLATZER™ Cardiac Plug (St. Jude Medical, Minneapolis, MN, États-Unis) pour 1 patient et Amulet™ (St. Jude Medical, Minneapolis, MN, États-Unis) pour les 2 autres. Il n’y a pas eu de complications péri-procédurales. Après un suivi de 8 ± 2 mois, nous n’avons pas observé de décès ni d’autre complication.
Conclusions
La technique de piégeage du thrombus est efficace et sure. Cette modification de la technique d’implantation pourrait permettre d’étendre les indications de fermeture percutanée de l’auricule gauche aux patients avec thrombus appendiculaire, considérés pour le moment non éligibles à ce traitement.
Background
Embolic stroke is the main complication that occurs in patients with atrial fibrillation (AF), with an annualized incidence ranging from 1.9% to 18.2% . Oral anticoagulation (OAC), using either vitamin K antagonists or the more recently introduced factor II/Xa inhibitors, is recommended in patients with a Cardiac failure, Hypertension, Age ≥ 75 years (Doubled), Diabetes, Stroke (Doubled) – Vascular disease, age 65–74 years and Sex category (Female) (CHA 2 DS 2 -VA 2 Sc) score ≥ 1, to reduce stroke risk in these patients. However, OAC is associated with severe haemorrhagic complications, and many patients discontinue this therapy a few years after treatment initiation .
Based on the concept that up to 90% of emboli from non-valvular AF originate in the left atrial appendage (LAA), percutaneous LAA closure has emerged as an alternative therapeutic option to OAC, for the prevention of embolic stroke in high-risk patients . Indeed, after exclusion of the LAA embolic source, the remaining risk is too small to warrant OAC, with its inherent bleeding risk. Indications for LAA closure are expanding widely, but these procedures remain contraindicated in several settings, including presence of thrombus in the LAA . During the LAA occlusion procedure, thrombus dislodgement may occur with the manipulation of sheaths or guidewires in the LAA. The presence of LAA thrombus despite appropriate antithrombotic therapy or in patients with a contraindication to systemic OAC is a major concern, as these patients are at high-risk of embolic complications.
Some authors have published brief reports of percutaneous LAA occlusion in patients with known thrombus within the LAA . In this article, we report procedural and short-term outcomes in a series of three patients with LAA thrombus in whom a modified technique was used to avoid manipulation of sheaths and catheters in the LAA, allowing a successful percutaneous closure procedure.
Methods
Patient selection
Between January 2011 and October 2014, we identified patients with LAA thrombus in whom LAA closure was attempted using a modified and simplified implantation technique.
Patients’ demographic data were analysed from medical records. CHA 2 DS 2 -VASc and Hypertension, Abnormal liver/renal function, Stroke, Bleeding, Labile international normalized ratio, Elderly (age > 65 years), Drugs/alcohol (HAS-BLED) scores were calculated. All patients gave written informed consent before the procedure.
Preprocedural management
All patients had cardiac computed tomography (CT) for the detection of LAA thrombus before the procedure, and for LAA anatomical assessment. In case of high suspicion of LAA thrombus on CT, the diagnosis was confirmed by transoesophageal echocardiography (TOE). Patients with LAA thrombus were treated with OAC or low-molecular-weight heparin for approximately 4 weeks, combined with single antiplatelet therapy (aspirin 160 mg/day), according to the patient’s status regarding contraindication to antithrombotic treatment. In case of OAC ineligibility or thrombus persistence despite appropriate therapy, LAA occlusion was considered using a modified implantation technique (see below). Patients with left atrial or left ventricular thrombus were excluded.
Implantation technique
All procedures were performed under general anaesthesia, fluoroscopy and real-time three-dimensional (3D) TOE guidance. Patients received unfractionated heparin intravenously to achieve an activated clotting time > 250 seconds. Baseline LAA measurements of the landing zone were obtained by TOE. Femoral venous access was obtained, and transseptal puncture was then performed under fluoroscopic and TOE guidance in the inferioposterior part of the fossa ovale. To prevent thrombus dislodgement during the procedure, any contrast injection or guidewire or catheter manipulation in the LAA was avoided. The transseptal sheath was advanced in the upper left pulmonary vein and an over-the-guide exchange was performed with the delivery sheath, using a 260-cm Amplatz Super Stiff™ J Guidewire (Boston Scientific, Marlborough, MA, USA). The wire and sheath were advanced carefully using TOE guidance, to avoid inadvertently entering the LAA. The delivery sheath was then pulled back gently from the vein and moved forward towards the LAA ostium, without engaging the latter. The operator took care to avoid entering the LAA with the sheath.
Optimal device sizing was achieved using 3D multimodality imaging, including preprocedural CT and two-dimensional/3D perprocedural TOE. The device size was chosen to be 10–20% larger than the measured landing zone diameter (using the usual anatomical landmarks, i.e. the left circumflex coronary artery and the LAA roof 1 cm inward from the tip of the ridge separating the LAA and the left upper pulmonary vein) . Device preparation was performed according to the manufacturer’s recommendations. After purging, the device was advanced to the distal end of the access sheath. Usually, a counterclockwise rotation of the sheath was performed to orientate it parallel to the LAA neck. For the AMPLATZER™ Cardiac Plug (St. Jude Medical, Minneapolis, MN, USA) and Amulet™ (St. Jude Medical, Minneapolis, MN, USA) prosthesis, the first half of the device (lobe) was delivered by sheath retraction, and the second half by pushing it forward. Then, the disc was deployed by further retracting the sheath while the operator pushed gently on the device. After confirming proper positioning using TOE and fluoroscopy and a sustained tug test, the device was released. Regarding device selection, the first implantations were performed with the AMPLATZER™ Cardiac Plug; a switch was made to the Amulet™ when it became available in France.
Follow-up
Transthoracic echocardiography (TTE) was performed 24 hours after the procedure in all patients. After device implantation, antithrombotic therapy was given according to LAA closure indication: patients with OAC contraindication received lifelong single antiplatelet therapy consisting of aspirin (160 mg/day) or clopidogrel (75 mg/day); patients with persistent LAA thrombus despite appropriate OAC treatment continued OAC after LAA closure. Follow-up was performed at clinical visits at 1, 3, 6, and 12 months, and yearly thereafter. TTE was performed at 1 month to evaluate device position. Control cardiac CT was performed at 3 months to evaluate device position and device-related thrombus, and to assess residual peridevice leak. In case of abnormal CT, TOE was performed to confirm the suspected diagnosis (i.e. thrombus or residual leak), according to our institutional protocol.
Major non-fatal complications were defined as embolic events (stroke, transient ischaemic attack, cardiac embolism), the need for emergency surgical intervention, life-threatening arrhythmias and pericardial tamponade. Minor complications were defined as minor bleeding or vascular complications without need for intervention.
Statistical analysis
Data are expressed as mean ± standard deviation or median (range) for continuous variables, and as number (percentage) for categorical variables. No statistical analysis was performed.
Results
During the study period, LAA closure was performed in three patients with echocardiographic contrast LAA thrombus in the University Hospital of Bordeaux. Patients were aged between 57 and 82 years at the time of intervention (mean age 74 ± 14 years old; two men) and had a high bleeding risk (mean HAS-BLED score 3 ± 0) as well as a high thromboembolic risk profile (mean CHA 2 DS 2 -VASc score 4.3 ± 0.5). Patient 1 had non-valvular AF with a mild valvular disease: moderate mitral regurgitation without stenosis and mild aortic stenosis (Doppler maximal peak velocity of 2.6 m/s without associated leak). Patients 1 and 2 had chronic AF, while patient 3 had paroxysmal arrhythmia. The LAA closure indication was OAC contraindication because of intracranial haemorrhage in patient 2, and persistent LAA thrombus despite appropriate antithrombotic therapy in patients 1 and 3. Patient 1 presented with multiple systemic embolisms despite optimal OAC. The mean baseline left ventricular ejection fraction was 53 ± 11%. The patients’ baseline demographic data are displayed in Table 1 .
| Case | Age (years) | Sex | AF type | CHA 2 DS 2 -VASc score | HAS-BLED score | Baseline antithrombotic therapy | LAAC indication |
|---|---|---|---|---|---|---|---|
| 1 | 57 | Male | Chronic | 4 | 3 | Aspirin + LMWH | Persistent thrombus despite OAC |
| 2 | 82 | Female | Chronic | 5 | 3 | Aspirin | OAC contraindication |
| 3 | 82 | Male | Paroxysmal | 4 | 3 | OAC | Persistent thrombus despite OAC |
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