P3721Clinical and echocardiographic outcomes after treatment of patent foramen ovale with two transcatheter occlusion devices: mononcenter observational study
Authors: Almalla M , Schroeder J , Altiok E , Alashkar M N , Kirschfink A , Lebherz C , Marx N , Alsaad M K 
Published: October 2019

Background

Percutaneous closure of patent foramen ovale (PFO) after cryptogenic stroke (CS) is strongly recommended in the current guidelines. Most available evidence has been obtained from randomized studies in which Amplatzer PFO occluder device or Groe occluder device were implanted. Several occluder devices are used off-label for percutaneous treatment of PFO. Rate of recurrent CS and rate of residual shunting after percutaneously occlusion of PFO varies between different occlusion devices. To date, there are no randomized clinical studies that compare the effectivity and safety of several devices in patients with CS.

Aim

The aim of this study was to compare rate of residual shunting and recurrent CS after percutaneus treatment of PFO with the most common used PFO occluder devises.

Methods

This was a retrospective, non-randomized, monocenter study. Between 2008 and 2014, all patients with CS or transient ischemic attack (TIA) treated with transcatheter occlusion of PFO with Amplatzer PFO occlusion device or Occlutech occlusion device were included. Patients were followed up at 1 and 6 months with contrast-enhanced transesophageal echocardiography (TEE), and at 3 months with contrast-enhanced transthoracic echocardiography. Primary endpoint was residual shunting at 6 months. Secondary endpoint was recurrent CS or TIA at 6 months after the procedure.

Results

220 consecutive patients (57±12 year, 131 men) were treated with Amplanz PFO occlusion device (140 patients) or Occlutech PFO occlusion device (80 patients) after CS or TIA. Procedural success was 100% in both groups. Residual shunting was observed directly after the procedure in 26 patients in the Amplatzer group and 22 patients in the Occlutech group (19% and 27%, respectively; p=0.003), at 1 months follow (15% and 25%, respectively; p=0.064) and at 6 months (9% and 16%, respectively; p=0.024). There was no significant difference between both groups according recurrent CS (0.7% and 0%, respectively; p=0.449). At 6 months follow up atrial fibrillation was detected in 2 patients from Amplatzer group and 5 patients from Occlutech group (1.4% and 6.0%, respectively; p=0.050). Death, aortic erosion and pericardial effusion was not observed in both groups.

Clinical and echocardiographic outcome Variable Amplatzer occluder device (N=140) Occlutech occluder device (N=80) p-value Clinical outcome at 6 months follow up   Death, n (%) 0 (0%) 0 (0%) 1.000   Stroke, n (%) 1 (1%) 0 (0%) 0.449   Transient ischemic attack, n (%) 0 (0%) 0 (0%) 1.000   Atrial fibrillation, n (%) 2 (1.4%) 5 (6%) 0.050   Aortic erosion, n (%) 0 (0%) 0 (0%) 1.000   Pericardial effusion, n (%) 0 (0%) 0 (0%) 1.000 Echocardiographic Outcome at 6 months follow up   Residual shunting after Implantation directly, n (%) 26 (19%) 22 (27%) 0.003   Residual shunting at one month, n (%) 21 (15%) 20 (25%) 0.064   Residual shunting at 6 months, n (%) 13 (9%) 16 (20%) 0.024

Conclusion

Percutaneous treatment of PFO after CS or TIA with Amplatzer PFO occluder device was associated with lower rate of residual shunting and lower rate of atrial fibrillation at 6 months follow up, whereas rate of recurrent CS and TIA was comparable between both groups.