Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives
Abstract
:1. Introduction
2. Device Specification
3. Periprocedural Outcomes
4. DRT and PDLs
5. Long-Term Outcomes
6. Anti-Thrombotic Therapy
7. Ongoing Trials and Future Directions
8. Conclusions
Author Contributions
Funding
Conflicts of Interest
References
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Trial | Design and Patient Selection | Patients | Key Findings |
---|---|---|---|
PROTECT AF | WATCHMAN vs. warfarinNon-inferiority Key Inclusion Criteria:
| Control (n = 244) Device (n = 463) |
|
PREVAIL | WATCHMAN vs. warfarin Non-inferiority Key Inclusion Criteria:
| Control (n = 138) Device (n = 269) |
|
PRAGUE-17 | LAAC device vs. DOAC Non-inferiority Key Inclusion Criteria: Nonvalvular AF and one of the following:
| Control (n = 201) Device (n = 201) |
|
AMULET IDE | AMULET vs. WATCHMAN Non-inferiority Key Inclusion Criteria:
| Amulet (n = 934) Watchman (n = 944) |
|
Parameter | Amulet | Watchman FLX | Watchman FLX Pro |
---|---|---|---|
Construct of the device | Self-expanding nitinol device with a distal lobe and a proximal disc | Self-expanding nitinol frame with PET with distal fluoroscopic marker | Self-expanding nitinol frame with HEMOCOAT technology covering |
Anchor mechanism | Stabilizing wires | Dual-row anchors | Dual-row anchors with three radiopaque markers |
Available sizes | 8 | 5 | 6 |
Size range | 16 mm, 18 mm, 20 mm, 22 mm, 25 mm, 28 mm, 31 mm, 34 mm | 20 mm, 24 mm, 27 mm, 31 mm, 35 mm | 20 mm, 24 mm, 27 mm, 31 mm, 35 mm, 40 mm |
Ostium coverage | 11–31 mm | 14–31.5 mm | 14–36 mm |
Sealing mechanism | Dual seal mechanism (disc and lobe) | Single seal mechanism (single lobe) | Single seal mechanism (single lobe) |
Access system |
|
|
|
Amulet | Watchman |
---|---|
Confirm proper device placement before release using echocardiography and fluoroscopy following CLOSE criteria C—At least 2/3 of the device lobe should be distal to the left Circumflex artery on echocardiography; L—The device Lobe should be slightly compressed and have good apposition to the left atrial appendage wall; O—The Orientation of the device lobe must be in line with the axis of the intended landing zone in the left atrial appendage; S—The disc must be Separated from the lobe; E—The disc will have a concave elliptical shape. | All criteria must be met prior to device release PASS criteria Position—Device is at the ostium of the LAA with the exclusion of all pectinate muscle; Anchor—Secure fixation anchors confirming device stability; Size—Device is compressed 10–30% of the original size; Seal—Effective sealing without peri-device leaks ledetected by color Doppler and/or angiographic assessment. |
Trial | Sample | Objective | Intervention | Control | Primary Outcomes | Follow-Up |
---|---|---|---|---|---|---|
CHAMPION-AF (NCT04394546) | 3000 | Evaluate LAAC with Watchman/FLX in NVAF patients eligible for long-term DOAC | Watchman/FLX | Long-term DOAC | Composite endpoint of ischemic stroke or SE; composite endpoint of ischemic stroke, SE, or CV death (tested for NI); nonprocedural major bleeding (tested for S) | 3 y |
CATALYST (NCT04226547) | 2650 | Evaluate LAAC with Amulet in patients with NVAF eligible for long-term DOAC | Amulet | Long-term DOAC | Composite endpoint of ischemic stroke or SE; composite endpoint of ischemic stroke, SE, or CV death (tested for NI); nonprocedural major bleeding (tested for S) | 3 y |
OCCLUSION-AF (NCT03642509) | 750 | Evaluate Amulet or Watchman in patients with NVAF and prior ischemic stroke or TIA eligible for long-term DOAC | Amulet or Watchman | Long-term DOAC | Composite endpoint of stroke, SE, all-cause mortality, and major bleeding | 5 y |
CLOSURE-AF (NCT03463317) | 1512 | Evaluate LAAC in patients with NVAF at high bleeding risk or contraindication to OAC | LAAC devices with CE approval | DOAC or VKA | Composite endpoint of stroke, SE, CV, or unexplained death and major bleeding | 2 y |
STROKECLOSE (NCT02830152) | 750 | Evaluate LAAC in patients with NVAF and ICH within 12 months | Amulet | Medical therapy | Composite endpoint of stroke, SE, all-cause mortality, and major bleeding | 5 y |
CLEARANCE (NCT04298723) | 550 | Evaluate LAAC in NVAF patients with a previous ICH | Watchman FLX | Medical therapy | Composite endpoint of stroke, SE, CV, or unexplained death and major bleeding | 2 y |
COMPARE-LAAO (NCT04676880) | 609 | Evaluate LAAC in patients with NVAF and contraindications for OAC | Watchman FLX or Amulet | Antiplatelets or no therapy | Time to first stroke event; time to first stroke, TIA or SE event; procedural complications | 5 y |
OPTION (NCT03795298) | 1600 | Evaluate LAAC with Watchman FLX vs. OAC in patients with NVAF undergoing catheter ablation for NVAF | Watchman FLX | DOAC or VKA | Composite endpoint of stroke, SE, or death; no procedure-related major bleeding | 3 y |
ASAP-TOO (NCT02928497) | 481 | Evaluate LAAC in patients with NVAF and contraindications for OAC | Watchman | Single antiplatelet or no therapy | Time to the first occurrence of ischemic stroke and SE; 7-day combined rate of death, ischemic stroke, SE, and complications requiring major CV or endovascular intervention | 5 y |
LAAOS 4 (NCT05963698) | 4000 | Assess whether LAAC prevents ischemic stroke or systemic embolism in patients with NVAF, at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation | Watchman plus OAC | OAC | Time to the first occurrence of ischemic stroke and SE | 4 y |
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Frazzetto, M.; Sanfilippo, C.; Costa, G.; Contrafatto, C.; Giacalone, C.; Scandura, S.; Castania, G.; De Santis, J.; Sanfilippo, M.; Di Salvo, M.E.; et al. Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives. J. Clin. Med. 2024, 13, 4651. https://doi.org/10.3390/jcm13164651
Frazzetto M, Sanfilippo C, Costa G, Contrafatto C, Giacalone C, Scandura S, Castania G, De Santis J, Sanfilippo M, Di Salvo ME, et al. Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives. Journal of Clinical Medicine. 2024; 13(16):4651. https://doi.org/10.3390/jcm13164651
Chicago/Turabian StyleFrazzetto, Marco, Claudio Sanfilippo, Giuliano Costa, Claudia Contrafatto, Chiara Giacalone, Salvatore Scandura, Giuseppe Castania, Jessica De Santis, Maria Sanfilippo, Maria Elena Di Salvo, and et al. 2024. "Watchman vs. Amulet for Left Atrial Appendage Closure: Current Evidence and Future Perspectives" Journal of Clinical Medicine 13, no. 16: 4651. https://doi.org/10.3390/jcm13164651