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The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Percutaneous left atrial appendage closure with concomitant dual-device implantation: a single-center observational
Antanas Gasys1, Roberto Galea1,2, Tommaso Bini1,3
1Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland.
Insights
Dual-device left atrial appendage closure (LAAC) using Amplatzer devices is a feasible and safe strategy for patients with complex, multilobed anatomies. This approach demonstrated technical success with no thromboembolic events at one-year follow-up.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Percutaneous left atrial appendage closure (LAAC) is a key stroke prevention method for atrial fibrillation (AF) patients.
- Complex left atrial appendage (LAA) anatomies can lead to incomplete sealing, potentially reducing LAAC efficacy.
Purpose of the Study:
- To evaluate the safety, feasibility, and efficacy of using two Amplatzer devices concurrently for LAAC in patients with complex, multilobed LAA anatomies.
- To present the largest cohort to date examining dual-device LAAC in challenging LAA morphologies.
Main Methods:
- A retrospective review of LAAC procedures at the University Hospital of Bern (2009-2025) identified 10 patients undergoing dual-device implantation.
- Data analyzed included baseline characteristics, procedural details (transesophageal echocardiography-guided or fluoroscopy-guided), device types (Amulet, ACP), and follow-up outcomes.
- Statistical analysis involved t-tests, Mann-Whitney U tests, and chi-square tests, with significance defined as p < 0.05.
Main Results:
- All 10 procedures achieved technical success, utilizing various Amplatzer device combinations in patients with confirmed multilobed LAA anatomy.
- One patient (10%) experienced a minor pericardial effusion within the first week.
- At one-year follow-up in nine patients, three (30%) developed pericarditis; no thromboembolic events or device-related complications were observed.
Conclusions:
- Concomitant dual-device LAAC with Amplatzer devices is a feasible strategy for complex, multilobed LAA anatomies.
- The procedure demonstrated acceptable short-term safety, though a potential increase in pericarditis risk warrants consideration.
- This approach offers a viable solution for stroke prevention in AF patients with challenging LAA morphologies.
Background:
Percutaneous left atrial appendage (LAA) closure (LAAC) is a proven stroke prevention strategy for patients with atrial fibrillation (AF). However, incomplete sealing in complex LAA anatomies may compromise efficacy.
Objectives:
This study evaluates the safety, feasibility, and efficacy of concomitant dual-device LAAC in multilobed anatomies, representing the largest cohort examined to date.
Methods:
We reviewed all LAAC procedures performed at the University Hospital of Bern between 2009 and 2025. Baseline characteristics, procedural details, and follow-up data were analyzed for patients receiving dual-device LAAC. Endpoints included technical success, complications, thromboembolic events, and device-related issues. Continuous data were expressed as mean ± standard deviation or median values, while categorical data were reported as percentages. Group comparisons were conducted using t-test, Mann-Whitney U test, or chi-square test. Differences were expressed as 95% confidence intervals, and a p-value of less than 0.05 was considered significant.
Results:
Of 1,307 LAAC procedures, 10 included dual-device implantation. The mean age of the patients was 71 years, and all patients were men. The Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, prior Stroke or TIA, Vascular disease, Age 65-74 years, Sex category (CHA2DS2-VASc) and Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol (HAS-BLED) scores were 3.5 ± 1.8 and 2.9 ± 1.4, respectively. Most patients (70%) had paroxysmal AF. Preprocedural and intraprocedural transesophageal echocardiography (TEE) confirmed multilobed LAA anatomy in all cases. Half of the procedures were fluoroscopy-guided with one delivery sheath and transseptal puncture, while the other half were TEE-guided with a double sheath and two transseptal punctures. Only Amplatzer devices were used: Eight procedures employed two devices of the same type [five Amulet, three Amplatzer Cardiac Plug (ACP)], and two procedures combined different types (Amulet + ACP, ACP + Amplatzer Vascular Plug). Technical success was achieved in all cases. Within the first week, one (10%) patient experienced a clinically non-clinically relevant pericardial effusion. At 1-year follow-up (completed in nine patients), three (30%) patients developed pericarditis. No thromboembolic events, device-related thrombosis, or device embolization occurred.
Conclusion:
In this small cohort of patients with complex multilobed LAA anatomy, concomitant implantation of two Amplatzer devices proved to be a feasible strategy with acceptable short-term safety, although potentially associated with an increased risk of pericarditis.
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