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SWISS-APERO

Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure

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Year of Publication: 2022

Authors: Roberto Galea, Federico De Marco, Nicolas Meneveau, ..., Marco Valgimigli

Journal: Circulation

Citation: Circulation. 2022;145:724–738. DOI: 10.1161/CIRCULATIONAHA.121.057859

Link: https://www.ahajournals.org/doi/10.1161/...NAHA.121.057859

Clinical Question

Is Amulet superior to Watchman FLX in terms of residual LAA patency and need for crossover to another device at 45 days after percutaneous LAA closure?

Bottom Line

Amulet was not superior to Watchman in terms of LAA patency at 45-day CCTA, but was associated with lower peridevice leak rates at TEE and higher procedural complications, with similar clinical outcomes at 45 days.

        Major Points
        First randomized trial comparing Amulet with Watchman FLX devices
Primary endpoint (crossover or LAA patency) similar between groups (67.6% vs 70.0%)
Different leak mechanisms: intradevice leaks more common with Amulet, peridevice/mixed leaks with Watchman
Amulet associated with higher procedural complications, mainly pericardial effusions and bleeding
TEE showed lower peridevice leak rates with Amulet (13.7% vs 27.5%)
Similar clinical outcomes at 45 days between both devices

      

Design

Study Type: Investigator-initiated, open-label, multicenter, randomized superiority clinical trial

Randomization: 1

Blinding: Clinical Events Committee members were blinded to patient allocation

Enrollment Period: June 2018 to May 2021

Follow-up Duration: 45 days

Centers: 8

Countries: Switzerland, France, Belgium, Italy

Sample Size: 221

Analysis: Intention-to-treat analysis using Stata Statistical Software

Inclusion Criteria

Age ≥18 years
Nonvalvular atrial fibrillation
Clinical indication for LAAC
CHA2DS2-VASc score ≥2
HAS-BLED score ≥3 or high-bleeding-risk features
LAA anatomy suitable for both devices confirmed by preprocedural CCTA and TEE

Exclusion Criteria

Creatinine clearance <30 mL/min
Enrollment in another cardiovascular device or investigational drug trial
LAA thrombus on imaging
LAA anatomy not suitable for both devices

Arms

Field	Control	Amulet
Intervention	Watchman 2.5 (n=25, 22.7%) or Watchman FLX (n=85, 77.3%) left atrial appendage closure device	Amplatzer Amulet left atrial appendage closure device
Duration	Single procedure with 45-day follow-up	Single procedure with 45-day follow-up

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Composite of justified crossover to nonrandomized device during procedure or residual LAA patency detected by CCTA at 45 days	Primary	70 patients (70.0%)	71 patients (67.6%)	2.40%	0.713
Peridevice leak at TEE	Secondary	27.5%	13.7%	0.5	0.020
Device-related thrombus at CCTA	Secondary	3.0%	0.9%		0.285
Intradevice leak at CCTA	Secondary	23.0%	44.8%	1.95	0.001
Mixed leak at CCTA	Secondary	14.0%	3.8%	0.27	0.010
Major procedure-related complications	Adverse	2.7%	9.0%	3.3	0.047
Any pericardial effusion	Adverse	6.4%	17.1%	2.69	0.013
Major bleeding (BARC 3-5)	Adverse	1.8%	7.2%	3.96	0.054
Death at 45 days	Adverse	3.6%	1.8%	0.5	0.409

Subgroup Analysis

Primary endpoint results were consistent across all prespecified subgroups including type of Watchman device used (2.5 vs FLX), age, sex, left ventricular function, diabetes, previous bleeding, and cerebrovascular events

Criticisms

Open-label design with devices easily distinguishable during imaging assessment
Not powered for clinical endpoints
Minority of patients received Watchman 2.5 vs FLX
Higher procedural complication rates than previously reported studies
Short 45-day follow-up precludes long-term clinical evaluation
Prognostic significance of residual LAA patency after percutaneous closure remains unclear

Funding

Study sponsored by University Hospital of Bern, Switzerland, with research grant support from Abbott

Based on: SWISS-APERO (Circulation, 2022)

Authors: Roberto Galea, Federico De Marco, Nicolas Meneveau, ..., Marco Valgimigli

Citation: Circulation. 2022;145:724–738. DOI: 10.1161/CIRCULATIONAHA.121.057859

Content summarized and formatted by NeuroTrials.ai.

SWISS-APERO

(2022)

Objective

To compare Amulet versus Watchman FLX devices in terms of residual left atrial appendage patency and clinical outcomes in patients undergoing percutaneous left atrial appendage closure

Study Summary

• Amulet was not superior to Watchman in terms of LAA patency at 45-day CCTA (67.6% vs 70.0%, P=0.713)
• Amulet had lower peridevice leak rates at TEE but higher procedural complications
• Clinical outcomes at 45 days were similar between groups

Intervention

Amulet vs Watchman 2.5/FLX devices for left atrial appendage closure

Inclusion Criteria

Patients ≥18 years with nonvalvular atrial fibrillation, CHA2DS2-VASc score ≥2, and HAS-BLED score ≥3 or high-bleeding-risk features

Study Design

Arms: Amulet (n=111) vs Watchman (n=110)

Patients per Arm: 111 and 110

Outcome

• Primary endpoint (crossover or LAA patency) occurred in 67.6% Amulet vs 70.0% Watchman (RR 0.97, P=0.713)
• Major procedure-related complications: 9.0% Amulet vs 2.7% Watchman (P=0.047)
• Peridevice leaks at TEE: 13.7% Amulet vs 27.5% Watchman (P=0.020)

Bottom Line

Major Points

First randomized trial comparing Amulet with Watchman FLX devices
Primary endpoint (crossover or LAA patency) similar between groups (67.6% vs 70.0%)
Different leak mechanisms: intradevice leaks more common with Amulet, peridevice/mixed leaks with Watchman
Amulet associated with higher procedural complications, mainly pericardial effusions and bleeding
TEE showed lower peridevice leak rates with Amulet (13.7% vs 27.5%)
Similar clinical outcomes at 45 days between both devices

Study Design

Study Type: Investigator-initiated, open-label, multicenter, randomized superiority clinical trial
Randomization: Yes
Blinding: Clinical Events Committee members were blinded to patient allocation
Sample Size: 221
Follow-up: 45 days
Centers: 8
Countries: Switzerland, France, Belgium, Italy

Primary Outcome

Definition: Composite of justified crossover to nonrandomized device during procedure or residual LAA patency detected by CCTA at 45 days

Control	Intervention	HR/OR	P-value
70 patients (70.0%)	71 patients (67.6%)	- (0.80-1.16)	0.713

Limitations & Criticisms

Open-label design with devices easily distinguishable during imaging assessment
Not powered for clinical endpoints
Minority of patients received Watchman 2.5 vs FLX
Higher procedural complication rates than previously reported studies
Short 45-day follow-up precludes long-term clinical evaluation
Prognostic significance of residual LAA patency after percutaneous closure remains unclear

Citation

Circulation. 2022;145:724–738. DOI: 10.1161/CIRCULATIONAHA.121.057859

View Original Publication →

SWISS-APERO

Comparison of Amulet Versus Watchman/FLX Device in Patients Undergoing Left Atrial Appendage Closure

Clinical Question

Bottom Line

Major Points

Design

Inclusion Criteria

Exclusion Criteria

Arms

Outcomes

Subgroup Analysis

Criticisms

Funding

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