Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale...

Area of Science:

• Cardiology
• Interventional Cardiology
• Medical Devices

Background:

• Patent foramen ovale (PFO) closure is established for preventing paradoxical thromboembolic events.
• Uncertainty exists regarding the impact of different occluder device designs on clinical outcomes.
• This study compares two widely used double-disc PFO occluders.

Purpose of the Study:

• To compare the outcomes of percutaneous PFO closure using the Abbott Amplatzer occluder (APO) and the Occlutech Figulla-Flex-II occluder (OPO).
• To evaluate the efficacy and safety of these devices in preventing recurrent paradoxical thromboembolic events.

Main Methods:

• A registry of consecutive patients undergoing percutaneous PFO closure with either APO or OPO between February 2017 and December 2022.
• Primary endpoint: effective PFO closure (residual shunt grade 0 or 1) at 6-month follow-up via contrast echocardiogram.
• Secondary endpoints: procedural efficacy, safety, and major adverse cardiovascular events.

Main Results:

• 193 patients (mean age 51.7 years) received either APO (62.2%) or OPO (37.8%).
• Primary indication was cryptogenic stroke (87.1%).
• Effective closure at 6 months was 95.8% (APO: 96.6% vs. OPO: 94.5%, P = .30). No significant difference between devices.
• Procedural success was 99.5% with one minor air embolism complication.

Conclusions:

• Percutaneous PFO closure is a safe and effective procedure for preventing paradoxical thromboembolic events.
• Both the Abbott Amplatzer and Occlutech Figulla Flex II PFO occluders demonstrate comparable efficacy and safety profiles.
• Device choice does not appear to significantly impact closure rates or major adverse events.