Left Atrial Appendage Closure Device
Built off the most studied, most implanted LAAC device in the world, WATCHMAN FLX is a proven alternative to long-term OAC therapy1 for stroke risk reduction in patients with non-valvular atrial fibrillation.
WATCHMAN FLX was studied in the PINNACLE FLX US IDE Clinical Trial. The study was designed to establish the procedural safety and closure efficacy of new generation LAAC device, WATCHMAN FLX.
- SURPASS assesses the safety and efficacy outcomes in patients in the NCDR-LAAO Registry that received a commercial WATCHMAN FLX device
- This SURPASS analysis includes 16,048 patients receiving a WATCHMAN FLX device between August 5, 2020 and March 31, 2021
- SURPASS will continue to assess WATCHMAN FLX patients included in the NCDR-LAAO Registry from August 2020 through August 2022 and will follow these patients through 2 years post-implant.
Mean baseline patient characteristics (N=16,048)
- Average age/years: 76.1 ± 7.9
- CHA2DS2-VASc: 4.8 ± 1.5
- HAS-BLED: 2.4 ± 1.0
- 40% women
- 62% with prior clinically relevant bleeding event
SURPASS demonstrated 0.37% major procedural adverse event rate within 7 days or hospital discharge in 16,048 commercial patients and confirmed the trusted safety profile of WATCHMAN FLX in real-world clinical practice setting.
The SURPASS Data reinforces the excellent safety profile WATCHMAN FLX demonstrated in the PINNACLE FLX Trial, with the largest (n=16,048) real-world WATCHMAN FLX patients studied to date.
Comparison with PINNACLE FLX2
- Meta-analysis (published in Heart Rhythm) of 4186 patients from 21 studies (a meta-analysis is a statistical technique used to systematically merge the findings of previous studies to calculate an overall or ‘absolute’ effect)
- 3187 Amulet implants
- 999 WATCHMAN FLX implants
- No difference in TE risk between groups
- CHA2DSC2-VASc: 4.3±1.5 for Amulet
- CHA2DSC2-VASc 4.2±1.5 for WATCHMAN FLX
- Data from a first imaging study performed within 3-month were used to assess the incidence of peri-device leaks >5mm and device-related thrombosis (DRT).
Safety endpoint was the occurrence of death, stroke, major bleeding, myocardial infarction, major vascular complications, device embolization, or pericardial effusion within 7 days post-procedure.
- WATCHMAN FLX superior on primary safety endpoint (0.6% FLX vs 4.7% Amulet, p<0.01)
- WATCHMAN FLX superior on overall pericardial effusion/tamponade (0.1% FLX vs 2.5% Amulet, p<0.01)
- WATCHMAN FLX superior on clinically relevant pericardial effusion/tamponade (0.01% FLX vs 0.7% Amulet, p=0.01)
- WATCHMAN FLX superior on peri-procedural major/intracranial bleeding (0.1% FLX vs 2.3% Amulet, p=0.01)
- 0 device embolizations occurred with WATCHMAN FLX vs. 15 with Amulet
- WATCHMAN FLX demonstrated lower DRT than Amulet (1% vs 1.6%)
- No difference was observed for death or stroke between groups
WATCHMAN FLX showed a trend towards higher procedural success (p=0.08). Procedural success was achieved in 99.9% of WATCHMAN FLX patients (99.4% for Amulet, P=0.08)
WATCHMAN FLX showed a trend towards more frequent appendage occlusion (leaks >5mm; p=0.06). WATCHMAN FLX demonstrated fewer peri-device leaks >5mm than Amulet (0.01% vs 0.34%, p=0.06)
- Single-center, retrospective study of LAAO implantation at Aarhus
University Hospital (Denmark) between 2018-2020.
1st cohort: Amplatzer Amulet (n=150) 2018 – 2019
2nd cohort: WATCHMAN FLX (n=150) 2019 – 2020
- Cardiac CT was performed 8 weeks after LAAO
WATCHMAN FLX Demonstrated Statistically Superior Complete Occlusion* vs Amulet (p=0.001)
Single Landing Zone and Overlapping Treatment Ranges
Complicated, Mis-Matched Measurements
Precision Placement Control
Trade-off Between Disc and Lobe Placement
Comparison of Amulet vs Watchman/FLX Devices in Patients Undergoing Left Atrial Appendage Closure - SWISS-APERO
PINNACLE FLX Clinical Study
PINNACLE FLX LATE-BREAKER PRESENTATION
Primary Outcome Evaluation of a Next Generation LAAC Device: The PINNACLE FLX Trial
presented by Dr. Shephal K. Doshi
May 8, 2020
HRS 2020 SCIENCE
- 400 patient, 29 US site, single arm, non-randomized trial evaluating WATCHMAN FLX for non-inferiority to safety and efficacy performance goals based on the WATCHMAN™ device.
- Follow-up: 45 days (+TEE), 6 months, 12 months (+TEE), 18 months, and 24 months
- Patient Characteristics: Average CHA2DS2-VASc of 4.2±1.5, Average HAS-BLED of 2.0±1.0
- Post Implant Drug Regimen: NOAC/ASA for 45 days, Clopidogrel/ASA to 6 months, ASA post 6 months
- Primary Safety Endpoint: All-cause death, ischemic stroke, systemic embolism, or device- or procedure-related adverse events requiring surgery or major endovascular intervention within 7 days following the procedure or by hospital discharge, whichever is later.
- Primary Efficacy Endpoint: The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months
- Secondary Efficacy Endpoint: The occurrence of ischemic stroke or systemic embolism at 24 months from the time of enrollment
- Inclusion/exclusion criteria is consistent with WATCHMAN clinical study inclusion/exclusion criteria. Patients must be eligible for short-term NOAC vs warfarin in previous clinical studies.
Primary Safety Endpoints
Primary Efficacy Endpoints
The rate of effective LAA closure defined as any peri-device flow ≤5mm demonstrated by TEE at 12 months.
** Performance goal pased on the rates observed in PREVAIL(1) and CAP2(2), minus a clinically relevant delta
Designed to Treat Widest Range of Patient Anatomies
WATCHMAN FLX sizes range from (20mm - 35mm)
Discussion of the PINNACLE FLX Clinical Trial
Dr. Ian Meredith, Executive Vice President, Global Chief Medical Officer, Boston Scientific