Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Nov 10;16(1):217.
doi: 10.1186/s12872-016-0391-3.

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

Jonas Neuser  1 , Muharrem Akin  1 , Udo Bavendiek  1 , Tibor Kempf  1 , Johann Bauersachs  1 , Julian D Widder  2
Affiliations

Mid-term results of interventional closure of patent foramen ovale with the Occlutech Figulla® Flex II Occluder

Jonas Neuser et al. BMC Cardiovasc Disord. .

Abstract

Background: Patients with a patent foramen ovale (PFO) who suffered from stroke, TIA or peripheral paradoxical embolism are at substantial risk for recurrent neurologic events and in need for secondary prevention. Interventional closure of PFO has been performed for over 20 years. Numerous devices have been developed and used for treatment. We investigated PFO closure with the third generation Occlutech Figulla® Flex II Occluder device.

Methods: Between 2012 and 2015 57 patients (mean age 47.3 ± 1.5 years) who had suffered from a thromboembolic event of unknown cause underwent transcatheter PFO closure with the Occlutech Figulla® Flex II Occluder at our department. 68.4 % of all patients had suffered from cryptogenic stroke, while TIA had occurred in 28.1 %. Almost all patients were diagnosed with an atrial septum aneurysm (90.9 %) and a severe right-to-left shunt grade 3: >20 microbubbles (92.0 %). Follow-up was done 6 months post intervention by clinical examination and transesophageal contrast echocardiography.

Results: No major periprocedural or in-hospital complication occurred. Closure was sufficient with no residual right-to-left shunt in 94.4 % of all patients at 6 months post implantation and only minimal residual shunt in three cases. There were no thrombotic formations associated to the occluder device. Atrial fibrillation occurred in one patient and a recurrent cerebral ischemic event was seen in one patient, who suffered from another TIA.

Conclusions: The Occlutech Figulla® Flex II Occluder device and its delivery system is safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism.

Keywords: Interventional PFO closure; Occlutech Figulla® Flex II; Patent foramen ovale.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Pictures of the Occlutech Figulla® Flex II. a Occlutech Figulla® Flex II ball-socket right atrial hub. b Occlutech Figulla® Flex II attached to the delivery system
Fig. 2
Fig. 2
Distribution of type of previous paradoxical embolic event
Fig. 3
Fig. 3
Distribution of right-to-left shunt size before interventional PFO closure
Fig. 4
Fig. 4
Distribution of right-to-left shunt 6 months after interventional PFO closure
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Webster MW, Chancellor AM, Smith HJ, Swift DL, Sharpe DN, Bass NM, Glasgow GL. Patent foramen ovale in young stroke patients. Lancet. 1988;2:11–12. doi: 10.1016/S0140-6736(88)92944-3. - DOI - PubMed
    1. Lechat P, Mas JL, Lascault G, Loron P, Theard M, Klimczac M, Drobinski G, Thomas D, Grosgogeat Y. Prevalence of patent foramen ovale in patients with stroke. N Engl J Med. 1988;318:1148–1152. doi: 10.1056/NEJM198805053181802. - DOI - PubMed
    1. Homma S, Di Tullio MR, Sacco RL, Mihalatos D, Li Mandri G, Mohr JP. Characteristics of patent foramen ovale associated with cryptogenic stroke. A biplane transesophageal echocardiographic study. Stroke. 1994;25:582–586. doi: 10.1161/01.STR.25.3.582. - DOI - PubMed
    1. Mas JL, Arquizan C, Lamy C, Zuber M, Cabanes L, Derumeaux G, Coste J, Patent Foramen O, Atrial Septal Aneurysm Study G Recurrent cerebrovascular events associated with patent foramen ovale, atrial septal aneurysm, or both. N Engl J Med. 2001;345:1740–1746. doi: 10.1056/NEJMoa011503. - DOI - PubMed
    1. Cabanes L, Mas JL, Cohen A, Amarenco P, Cabanes PA, Oubary P, Chedru F, Guerin F, Bousser MG, de Recondo J. Atrial septal aneurysm and patent foramen ovale as risk factors for cryptogenic stroke in patients less than 55 years of age. A study using transesophageal echocardiography. Stroke. 1993;24:1865–1873. doi: 10.1161/01.STR.24.12.1865. - DOI - PubMed

MeSH terms