Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure

Galea, Roberto; Marco, Federico De; Aminian, Adel; Meneveau, Nicolas; Anselme, F.; Gräni, Christoph; Huber, Adrian Thomas; Teíger, Emmanuel; Iriart, Xavier; Angelillis, Marco; Brugger, Nicolas; Spirito, Alessandro; Corpataux, Noé; Franzone, Anna; Vranckx, Pascal; Fischer, Urs; Pedrazzini, Giovanni; Bedogni, Francesco; Windecker, Stephan; Räber, Lorenz; Valgimigli, Marco

doi:10.1007/s12265-020-10095-4

Cited by 8 publications

(14 citation statements)

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“…The study rationale and design have been reported previously. 9 The trial was designed by the principal investigator (M.V.) and sponsored by the University Hospital of Bern, Switzerland, which was responsible for implementing, conducting, analyzing, and reporting trial procedures and findings.…”

Section: Methods Study Designmentioning

confidence: 99%

“…Further key exclusion criteria included creatinine clearance of <30 mL/min and enrollment in another cardiovascular device or investigational drug trial. 9 Detailed inclusion and exclusion criteria are shown in Table S1.…”

Section: Methodsmentioning

confidence: 99%

“…The delayed scan (venous phase) was executed 60 seconds after the beginning of the standard scan to allow contrast equilibration within the blood pool. TEEs were performed according to the previously described protocol 9 and reported in the Supplemental Material to assess the presence and size of peridevice leak (PDL) and device-related thrombus (DRT). Once the images were acquired, they were sent to the coordinating center for the central assessment by the Imaging Core Laboratory.…”

Section: Follow-up At 45 Daysmentioning

confidence: 99%

“…LAA patency and type of leaks were centrally adjudicated by the Imaging Core Laboratory (Figure 1). More details regarding end point definitions, adjudication methods, and Imaging Core Laboratory interreader agreement were previously described 9 and are reported in the Supplemental Material. Secondary end points included LAA patency at 45-day TEE, any (the composite of death, cerebrovascular event, systemic or pulmonary embolism, air embolism, any bleeding, any pericardial effusion, vascular access complication, device-related complication, or acute kidney injury occurring within 7 days or thereafter if deemed procedure related) or major (as the composite of death, cerebrovascular event, systemic embolism, Bleeding Academic Research Consortium 3 or 5 bleeding, clinically relevant pericardial effusion, device embolization, and acute kidney injury within 7 days or thereafter if deemed procedure related) procedure-related complications, DRT at 45 days with CCTA and TEE, LAA patency on the venous phase (the latter defined as a LAA density ≥100 HU or ≥150% of that measured at the same site on arterial phase), 16 and clinical outcomes in terms of all-cause or cardiovascular death, overall, ischemic or hemorrhagic stroke, systemic or pulmonary embolism, spontaneous myocardial infarction, and Bleeding Academic Research Consortium type bleeding.…”

Section: Study Outcomesmentioning

confidence: 99%

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

et al. 2022

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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

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Section: Methods Study Designmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Follow-up At 45 Daysmentioning

confidence: 99%

Section: Study Outcomesmentioning

confidence: 99%

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

et al. 2022

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“…Что касается РКИ, сравнивающих ACP/Amulet с Watchman, то исследование Amplatzer™ Amulet™ LAA Occluder с участием 1878 пациентов (Amulet IDE) завершилось, и результаты ожидаются в 2021 году, в то время как сравнение Amulet и Watchman с участием 200 пациентов (SWISS-APERO), продолжается [20,21].…”

Section: рис 3 частота достижения суммарной клинической эффективности в группах сравненияunclassified

Experience with various occluder types for endovascular hemodynamic isolation of the left atrium appendage in patients with non-valvular atrial fibrillation

Певзнер

Меркулов

Arutyunyan

et al. 2021

Vestnik aritmologii

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The aim of our study was to evaluate implantation efficacy and safety across various occluder types and to identify factors determining device selection.Methods. This single-site prospective observational study included patients above the age of 40 years with non-valvular atrial fibrillation (AF) and high thromboembolic risk, undergoing endovascular isolation of the left atrium appendage (LAA) with Watchman or Amplatzer Cardiac Plug/Amulet devices. Occluders were implanted to patients without either had contraindications to anticoagulant therapy (ACT) or refused ACT. We evaluated technical aspects of device implantation, short- and long-term outcomes of the intervention over 3 years of follow-up.Results. 90 patients were enrolled in the study (62 into the Watchman arm and 28 into the Amplatzer arm). Interventions were technically successful in 89 cases. In 1 patient (1/90, 1.1%) technical success was not achieved due to device migration (Amplatzer Amulet). The incidence of early (occurring within˂ 24 hours) implantation complications was 0% in the Watchman arm, and 3.6% in the Amplatzer arm (1/28) (р=0.135) (device migration). The cumulative incidence of all in-hospital complications was 11.3% and 14.3%, respectively (р=0.734). No significant differences between arms were found in the incidence of device thrombosis within 90 days post-implantation (3.3% in the Watchman’s arm and 8.3% in the Amplatzer arm, р=0.316). During the observation period, there were no significant differences in comparison groups in the incidence of net clinical efficacy endpoint events (р=0.58). The bleeding rate was 17.7% and 14.3%, respectively, р=0.769. No factors influencing the choice of the device could be identified reliably; however, there was a trend towards Watchman preference for appendage anatomic variants such as broccoli and cactus. Amplatzer was preferred in patients with contraindications to ACT.Conclusion. Implantation of Watchman and Amplatzer Amulet occluders is equally effective and safe in preventing thromboembolism in patients with AF not receiving ACT for various reasons. The individual choice of a device may be influenced by appendage anatomy and indications to occluder implantation.

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Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment

Yoon,

Amoah,

Galo

et al. 2024

Cathet Cardio Intervent

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BackgroundLimited data exists regarding incidence, progression, and predictors of left atrial appendage (LAA) sealing after transcatheter LAA closure. We aimed to evaluate the incidence, progression, and predictive factors associated with LAA sealing after LAA closure.MethodsThis study includes patients who underwent successful LAA closure with Watchman FLX device and had both pre‐ and postprocedural computed tomography (CT). Postprocedural CT was performed 45 days after LAA closure and used to evaluate residual LAA patency. Patient who had residual LAA patency at 45 days underwent 1‐year follow‐up CT.ResultsA total of 105 patients (mean age: 75.2 ± 9.6 years; 53.3% female) who underwent successful LAA closure with Watchman FLX device and had pre‐ and postprocedural CT at 45 days were included. Residual patency was observed in 35 (33.3%) patients: 21 (20.0%) patients showed complete contrast opacification in LAA (complete LAA patency) while 14 (13.3%) patients showed contrast opacification only in the distal LAA (distal LAA patency). Among patients with residual LAA patency at 45 days, the rate of LAA sealing at 1 year was significantly higher in the distal LAA patency group than in the complete LAA patency group (75.0% vs. 16.7%; p = 0.019). Increased depth oversizing was associated with both distal LAA patency and complete LAA patency.ConclusionPostprocedural CT at 45 days detected patent LAA in one‐third of patients after LAA closure. LAA sealing was more frequently observed at 1 year among the distal LAA patency group than the complete LAA patency group.

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Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure

Cited by 8 publications

References 38 publications

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

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

Experience with various occluder types for endovascular hemodynamic isolation of the left atrium appendage in patients with non-valvular atrial fibrillation

Incidence, progression, and predictors of left atrial appendage sealing after Watchman FLX device implantation with computed tomographic assessment

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