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Close up view of the WATCHMAN implant on a blue background

SURPASS one-year results 

SURPASS one-year outcomes: Real-world experience with the WATCHMAN FLX™ Left Atrial Appendage Closure Device.

SURPASS: an excellent safety profile

The SURPASS one-year outcomes analysis of the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry™ now includes the largest number of commercial WATCHMAN FLX Device patients to date. These data continue to support the best-in-class safety of the WATCHMAN FLX Device with a 0.45% major procedural adverse event rate within seven days or hospital discharge, whichever is later, and 98% implant success in >97,000 real-world, non-valvular atrial fibrillation (NVAF) patients.1

Study design:

  • The objective of this SURPASS analysis is to assess long term safety and efficacy outcomes at one year with WATCHMAN FLX Device in a routine, real-world setting
  • This analysis includes the largest commercial WATCHMAN FLX Device patient population to date, with 97,185 patients implanted between August 2020 and September 2022

Patient characteristics: 

Age: 76.2 ±7.9 Years​

CHA2DS2-VASc Score: 4.8±1.5

HAS-BLED Score: 2.4±1.0​

Women: 41%​ 

Clinically Relevant Bleeding: 56.1%

Safety endpoint

Composite outcome of all-cause death, ischemic stroke, systemic embolism, or device/procedure-related events requiring open-cardiac surgery or major endovascular intervention between device implantation and seven days or hospital discharge, whichever is later.


 

Key safety endpoints*

The SURPASS one-year outcomes analysis reported a 0.45% major procedural adverse event rate within seven days or at hospital discharge, demonstrating the unmatched safety profile observed in both controlled and real-world analyses.

0.45%
SURPASS one-year1
(N=97,185)
0.37%
SURPASS early results 2
(N=16,048)
0.5%
PINNACLE FLX 3
(N=400)
0.6%
Meta-analysis4
(N=999)

 

*within seven days or discharge

Procedural success

The SURPASS data reinforces the procedural success of the WATCHMAN FLX Device with 98% of patients implanted (N=97,185)1 across nearly all anatomies in a real-world setting. These findings confirm that the real-world experience with the WATCHMAN FLX Device replicates those observed in clinical trial outcomes.

Procedural Success graph

The one-year SURPASS data confirms the excellent safety profile demonstrated by the WATCHMAN FLX Device in the PINNACLE FLX trial, based on the largest WATCHMAN FLX Device patient population to date (N=97,185).​ 

WATCHMAN FLX Device

Comparison with PINNACLE FLX through one year3

Comparison with PINNACLE FLX Chart.

Proven stroke reduction

The WATCHMAN Device delivers proven stroke reduction in the largest and highest risk patient population studied to date across the WATCHMAN platform.​

1.5%
All stroke rate
An orange icon of a brain with a stroke spot on it.
1.2%
Ischemic stroke rate

Learn more about the WATCHMAN FLX™ Pro LAAC Device

Explore the WATCHMAN FLX Pro Device

References

1. Kapadia SR et al. Outcomes with the WATCHMAN FLX in Everyday Clinical Practice from the NCDR Left Atrial Appendage Occlusion Registry, Circulation: Cardiovascular Interventions, 2024. 

2. Kapadia, CRT 2022.  

3. ​Kar, Circulation 2021. ​ 

4. Della Rocca et al. Heart Rhythm 2022. 

5. ​Ellis, Heart Rhythm, 2021. ​ 

6. Korsholm, WM FLX First Experience, JACC, 2020.​ 

7. Bergmann, Alster Registry, Presented ePCR 2021. ​ 

8. Betts, EHRA 2022. ​ 

9. Galea, SWISS APERO Trial, Circulation, 2021. ​ 

10. Freeman, HRS 2022​​.