Arrhythmias & electrophysiologyCohort study
Outcomes of Left Atrial Appendage Occlusion With a Coated Device
- prospective, multicenter, post-market-approval study
- 32 centers in the United States
Authors' conclusion
The HEAL-LAA study demonstrates that the novel device achieves excellent early closure at 45 days and favorable 6-month clinical outcomes, supporting its safety and effectiveness for LAAC. Safety and effectiveness was sustained through 12 months. Overall, results are similar to the predecessor device, and more targeted studies are needed to assess incremental value of the coating.
Study context
- Population
- Patients indicated for left atrial appendage closure (LAAC) (atrial fibrillation) receiving the WATCHMAN FLX Pro deviceenrolled across 32 centers
- Participants
- 500 patients
- Exposure
- WATCHMAN FLX Pro against performance goals
- WATCHMAN FLX Pron = 500
- Outcome
- Peridevice leak >5 millimeters on transesophageal echocardiography (primary effectiveness endpoint; performance goal <5%)
- Follow-up
- 45 days
Main finding
As reported in the abstract
WATCHMAN FLX Pro
0
events
- Complete seal
- 82.7%
Observational data: associations, not effects.
Further findings
Composite of all-cause mortality, stroke, systemic embolism, or major bleeding (primary safety endpoint; performance goal <21%) · 6 months and 12 months
- 6 months
- 11.1%
- 12 months
- 15.3%
- performance goal of <21%
Complete seal or small leak ≤3 mm · 45 days and 12 months
- 45 days
- 99.8%
- 12 months
- 98.8%
Postprocedure antithrombotic regimens
- Direct oral anticoagulants with or without aspirin
- over 50%
- Dual antiplatelet therapy
- 33%
Original publication
Summarised from the published abstract; every number is checked against it