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Close up view of the WATCHMAN implant on a blue background

SURPASS real-world data

Real-world experience with the WATCHMAN FLX Implant: SURPASS one-year outcomes
 

The SURPASS analysis

The SURPASS one-year outcomes analysis of the NCDR-LAAO Registry™ now includes the largest number of commercial WATCHMAN FLX™ Implant patients to date. These data continue to support the best-in-class safety of the WATCHMAN FLX Implant 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 the SURPASS analysis is to assess long term safety and efficacy outcomes at one year with WATCHMAN FLX in a routine, real-world setting

  • This analysis includes the largest commercial WATCHMAN FLX 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 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 0.45% major procedural adverse event rate within seven days or hospital discharge demonstrated in the SURPASS one-year outcomes analysis further supports the unmatched safety profile observed in separate controlled and real-world analyses.

SURPASS key safety endpoints graph

*within seven days or discharge

Procedural success

SURPASS data reinforces the WATCHMAN FLX Implant procedural success with 98% of patients implanted (N=97,185)1 across nearly all anatomies in a real-world setting, confirming the WATCHMAN FLX Implant real-world experience replicates clinical trial outcomes.

Procedural Success graph

*within seven days or discharge

The one-year SURPASS data confirm the excellent safety profile the WATCHMAN FLX Implant demonstrated in the PINNACLE FLX trial, with the largest (N=97,185) WATCHMAN FLX Implant patient population to date. 

WATCHMAN FLX Device

Comparison with PINNACLE FLX through one year3

Comparison with PINNACLE FLX Chart.

Proven stroke reduction

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

stroke statistics and orange brain icon

Learn procedural and short-term follow-up outcomes of WATCHMAN FLX Implant vs. Amplatzer™ Amulet™ Occluder

Next: Meta-analysis

References 

1. Late Breaking Clinical Trial at CRT 2023, Presented by Samiar Kapdia.​ 

2. Kapadia, CRT 2022.  

3. Kar, Circulation 2021. ​ 

4. Ellis, Heart Rhythm, 2021. ​ 

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

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

7. Betts, EHRA 2022. ​ 

8. Galea, SWISS APERO Trial, Cirulation, 2021. ​ 

9. Freeman, HRS 2022​​. 

10. Kapadia et al. Real-world Outcomes with WATCHMAN FLX: Early Results from SURPASS. Late Breaking Clinical Trial, CRT 2022.