scholarly journals Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial

Circulation ◽  
2021 ◽  
Author(s):  
Roberto Galea ◽  
Federico De Marco ◽  
Nicolas Meneveau ◽  
Adel Aminian ◽  
Frédéric Anselme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Cardiac Computed Tomography ◽  
Atrial Appendage ◽  
Clinical Trial Registration ◽  
Cardiac Computed Tomography Angiography ◽  
Procedural Complications

Background: No study has so far compared Amulet with the new Watchman FLX in terms of residual left atrial appendage (LAA) patency or clinical outcomes in patients undergoing percutaneous LAA closure (LAAC). Methods: In the investigator-initiated SWISS APERO trial, patients undergoing LAAC were randomized (1:1) open-label to receive Amulet or Watchman 2.5 or FLX (Watchman) across 8 European centres. The primary endpoint was the composite of justified crossover to a non-randomized device during LAAC procedure or residual LAA patency detected by cardiac computed tomography angiography (CCTA) at 45 days. The secondary endpoints included procedural complications, device related thrombus (DRT), peridevice leak (PDL) at transesophageal echocardiography (TEE) and clinical outcomes at 45 days. Results: Between June 2018, and May 2021, 221 patients were randomly assigned to Amulet (111 [50.2%]) or Watchman (110 [49.8%]), of whom 25 (22.7%) patients included before October 2019 received Watchman 2.5, and 85 (77.3%) patients received Watchman FLX. The primary endpoint was assessable in 205 (92.8%) patients and occurred in 71 (67.6%) Amulet and 70 (70.0%) Watchman patients respectively (risk ratio [RR] 0.97 [95% CI 0.80- 1.16]; P=0.713). A single justified cross-over occurred in an Amulet patient who fulfilled LAA patency criteria at 45-day CCTA. Major procedure related complications occurred more frequently in the Amulet group (9.0% vs. 2.7%; P=0.047), owing to more frequent bleeding (7.2% vs.1.8%). At 45 days, the PDL rate at TEE was higher with Watchman than Amulet (27.5% vs. 13.7%, p=0.020), albeit none was major (i.e. > 5 mm), whereas DRT was detected in 1 (0.9%) patient with Amulet and 3 (3.0%) patients with Watchman at CCTA and in 2 (2.1%) and 5 (5.5%) patients at TEE, respectively. Clinical outcomes at 45 days did not differ between the groups. Conclusions: Amulet was not associated with lower rate of the composite of crossover or residual LAA patency compared with Watchman at 45-day CCTA. Amulet, was however associated with lower PDL rates at TEE, higher procedural complications and similar clinical outcomes at 45 days compared with Watchman. The clinical relevance of CCTA-detected LAA patency requires further investigation. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT03399851

Cardiac Computed Tomography Angiography for Left Atrial Appendage Closure

2016 ◽  
Vol 32 (8) ◽  
pp. 1033.e1-1033.e9 ◽  
Author(s):  
Jacqueline Saw ◽  
Joao Pedro Lopes ◽  
Mark Reisman ◽  
Patrick McLaughlin ◽  
Savvas Nicolau ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Computed Tomography Angiography ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Cardiac Computed Tomography ◽  
Atrial Appendage ◽  
Left Atrial Appendage Closure ◽  
Cardiac Computed Tomography Angiography

scholarly journals One year outcome and analysis of peri-device leak of left atrial appendage occlusion devices

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
M Mansour ◽  
E Harnay ◽  
A Al Ayouby ◽  
V Mansourati ◽  
Y Jobic ◽  
...  
Keyword(s):  
Left Atrial ◽  
Left Atrial Appendage ◽  
Cardiac Computed Tomography ◽  
Male Gender ◽  
Atrial Appendage ◽  
P Value ◽  
Cardiac Computed Tomography Angiography ◽  
Landing Zone ◽  
Left Atrial Appendage Occlusion ◽  
Maximal Diameter

Abstract Background The prevalence of peri-device leak (PDL) of left atrial appendage occlusion (LAAO) devices has been previously reported. However, there have been only few data that compared different existing devices. The aim of this study was to assess the incidence of PDL with both devices WATCHMAN® and AMPLAZER Amulet®, and to evaluate the clinical outcome at 12 months. Methods Consecutive patients who underwent LAAO between January 2018 and 2020 were randomly assigned to either WATCHMAN or AMPLATZER Amulet implantation based on a systematic two-week alternation between both devices. LAA measurements were assessed using cardiac computed tomography angiography (CCTA) prior to, and transesophageal echocardiography (TEE) during the procedure. At 8 weeks post-LAAO, patients underwent TEE and/or CCTA to identify the presence of PDL and/or device-related complications. Patients were then followed for 12 months to identify major adverse cardiovascular/embolic events. Results The cohort consisted of 51 patients (25 WATCHMAN, 26 AMPLATZER Amulet; mean age 76±7 years; male gender 76%). Both groups were identically matched for demographics, comorbidities and indication for LAAO. There were 19 patients who had PDL (13 WATCHMAN vs 6 AMPLATZER Amulet, P-value=0.033). Of them, 8 (15%) patients had significant PDL (7 WATCHMAN vs. 1 AMPLATZER Amulet, P-value=0.018). On CCTA, the landing zone maximal diameter of the AMPLATZER Amulet device had the strongest correlation with the final deployed device size (Spearman'rho 0.92, P-value<0.0001). In the multivariate analysis, male gender and device type were independent predictors of any PDL (P-values 0.016 and 0.031, respectively). On a mean follow-up of 12 months, the total number of events was more prevalent in the WATCHMAN group (P-value 0.008), but the incidence of cardio-embolic events reached borderline significance (16% vs. 0%, P-value=0.051). Conclusions Among patients who underwent LAAO, almost 15% had significant PDL with the majority belonging to the WATCHMAN group. Still, larger studies are warranted to evaluate its effectiveness in stroke prevention. FUNDunding Acknowledgement Type of funding sources: None. Table 1 Table 2

Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)

EP Europace ◽  
2020 ◽  
Vol 22 (6) ◽  
pp. 916-923
Author(s):  
Caroline Kleinecke ◽  
Jiangtao Yu ◽  
Philip Neef ◽  
Eric Buffle ◽  
Stefano de Marchi ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Atrial Appendage ◽  
Comparable Efficacy ◽  
Left Atrial Appendage Closure ◽  
Bleeding Events ◽  
Safety Endpoint ◽  
Procedural Complications

Abstract Aims This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC). Methods and results Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66–1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29–1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55–1.12; P = 0.26) were similar for both groups. Conclusion This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.

Sign in / Sign up

Export Citation Format

Share Document