Turk Kardiyol Dern Ars. 2021; 49(1): 29-39 | DOI: 10.5543/tkda.2020.06699
Long-term follow-up outcomes in a real-world study cohort after percutaneous patent foramen ovale closure
Ahmet Hakan Ateş1
, Hikmet Yorgun1
, Uğur Canpolat1
, Yusuf Ziya Şener1
, Metin Okşul1
, Ergun Barış Kaya1
, Mehmet Levent Şahiner1
, Mehmet Akif Topcuoğlu2
, Ethem Murat Arsava2
, Kudret Aytemir11
Department of Cardiology, Hacettepe University Faculty of Medicine, Ankara, Turkey2
Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, Turkey
OBJECTIVE In recent years, percutaneous closure of a patent foramen ovale (PFO) has gained widespread use. This study is an evaluation of the safety and efficacy of the Figulla and Amplatzer devices for PFO closure, including long-term follow-up results.
METHODS A total of 305 patients (43.6% male; mean age: 43.25±10.98 years) who underwent percutaneous PFO closure between 2003 and 2019 were enrolled. The Risk of Paradoxical Embolism (RoPE) score was calculated to predict the recurrence risk of cerebrovascular events due to PFO. Transthoracic echocardiography was used during the procedure.
RESULTS The devices were successfully implanted in all patients. The in-hospital periprocedural complications recorded were atrial fibrillation in 1 patient (0.3%), supraventricular tachycardia in 1 patient (0.3%), and femoral hematoma in 3 patients (1%). The procedure time and fluoroscopy time was 21.92±2.93 minutes and 2.19±0.24 minutes, respectively. Recurrent ischemic stroke or transient ischemic attack (TIA) was observed in 7 (2.2%) patients during the median 85.77 months (25th-75th percentile: 10.21108.00 months) follow-up. The RoPE score was significantly lower in patients with recurrent ischemic cerebral event (stroke or TIA) compared with asymptomatic patients (p<0.001). Kaplan-Meier curve analysis revealed that there was no significant difference between PFO device types (Amplatzer: 2.4% vs. Figulla: 3.3%) in terms of recurrent ischemic cerebral events during follow-up (log-rank; p=0.642).
CONCLUSION Percutaneous PFO closure was safe, feasible, and effective. Our study confirmed the efficacy and safety of transthoracic echocardiogram guidance during percutaneous closure of PFO, which shortens the procedure time. A lower RoPE score was related to the recurrence risk of ischemic cerebrovascular events.
Occluder device, patent foramen ovale, Risk of Paradoxical Embolism score.
How to cite this article
Ahmet Hakan Ateş, Hikmet Yorgun, Uğur Canpolat, Yusuf Ziya Şener, Metin Okşul, Ergun Barış Kaya, Mehmet Levent Şahiner, Mehmet Akif Topcuoğlu, Ethem Murat Arsava, Kudret Aytemir. Long-term follow-up outcomes in a real-world study cohort after percutaneous patent foramen ovale closure. Turk Kardiyol Dern Ars. 2021; 49(1): 29-39
Corresponding Author: Yusuf Ziya Şener, Türkiye