Residual Shunt After Patent Foramen Ovale Device Closure in Patients With Cryptogenic Stroke
Condition: Patent Foramen Ovale; Closure; Foramen Ovale
MeSH terms: Ischemic Stroke; Foramen Ovale, Patent
Study type: Observational

Summary: 
      Among consecutive 47 cryptogenic stroke patients who underwent PFO closure, a serial
      follow-up bubble contrast TEE at 3 and 9 months after the index procedure was completed in 38
      patients (81%, 46±10 years, 19 men). To evaluate the efficacy of PFO closure, the incidence
      of any- and significant residual shunt (≥moderate) was assessed.
    

Detailed description: 
      The current investigation analyzed the date from the Gachon University Gil Medical Center PFO
      registry. Between March 2014 to February 2017, all consecutive 47 patients with ischemic
      stroke and PFO documented by bubble contrast with no other identifiable cause of the ischemic
      event, such as, carotid or intracranial artery stenosis, atrial fibrillation, and thrombus,
      or atheromatous plaque at the aortic arch (i.e. CS), were analyzed. PFO closure was
      determined according to the heart-brain team's discretion (the team consisted of an
      interventional cardiologist, an echocardiographer cardiologist, a neurologist, and a
      radiologist) based on clinical data, echocardiographic findings, and patients' preference.
      The Gore® Septal Occluder (WL Gore & Associates, Inc., Newark, DE, USA) (n=19) and the
      Amplatzer® PFO occluder (St. Jude Medical, Inc. St.Paul, MN, USA) (n=19) and were used. The
      Occlutec® PFO occluder was used in one patient who were excluded from the analysis. The
      Institutional Review Board of Gachon University Gil Medical Center approved this study and
      all patients provided written informed consent prior to enrollment.
    

Intervention name(s): Amplatzer® PFO occluder or Gore® Septal Occluder
Intervention type(s): Device
Intervention description(s): The closure procedure was performed under general anesthesia. After achieving femoral venous access, the PFO was crossed with a 5F multipurpose catheter, which was advanced into the left upper pulmonary vein and then exchanged over a 0.035 inch J-tipped stiff guidewire for an 8F or 9F guiding sheath. Procedural anticoagulation was initiated with 5000 units of intravenous heparin. After then additional heparin was administrated throughout procedure to maintain an activated clotting time of ≥250 seconds. Device size was selected based on TEE measurements of the distance between the PFO and the aortic root.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        all consecutive 47 patients with ischemic stroke and PFO documented by BCTEE with no other
        identifiable cause of the ischemic event, such as, carotid or intracranial artery stenosis,
        atrial fibrillation, and thrombus, or atheromatous plaque at the aortic arch (i.e. CS),
        were analyzed. PFO closure was determined according to the heart-brain team's discretion
        (the team consisted of an interventional cardiologist, an echocardiographer cardiologist, a
        neurologist, and a radiologist) based on clinical data, echocardiographic findings, and
        patients' preference.
      
Keywords: patent foramen ovale; PFO closure; residual shunt; bubble contrast transesophageal echocardiography