title: Clinical evaluation of a novel occluder device (Occlutech) for percutaneous transcatheter closure of patent foramen ovale (PFO).
abstract: BACKGROUND
  We investigated the safety, feasibility and usefulness for closure of PFO with the new nitinol meshwire PFO-occluder device (Occlutech Figulla-single layer occluder) with an unique braiding technology which allows a 50% reduction of meshwork material on the left atrial side in combination with a greater flexibility as compared to the Amplatzer occluder device.
  
  
  METHODS
  The retention discs of the new PFO Occlutech Figulla single layer device (23/25 mm) are connected by a 3 mm waist in the centre with only one right atrial side hub. The left atrial disc is a single flat layer covered by an ultrathin polyethylene terephthalate (PET) patch. We investigated the safety, feasibility and usefulness for closure of PFO in a multicenter clinical trial. Indications for closure included cryptogenic stroke with evidence of a patent foramen ovale in transesophageal echocardiography (PFO max. diameter 13 mm according to sizing balloon). The device was implanted in 36 patients (mean age 57, 18-80 years) by means of fluoroscopy and transesophageal echocardiography (TEE) using a 9 French delivery sheath and employing a femoral vein approach. Both acetylsalicylacid 100 mg/d (6 months) and clopidogrel 75 mg/d (3 months) were administered post interventional. A transthoracal (TTE) and transesophageal echocardiography follow-up examination was performed after 1, 2 and 6 months (TTE day 30 and 180; TEE day 60).
  
  
  RESULTS
  The device was successfully implanted in 36 pts. In one patient PFO implantations was attempted but not crossed with a guide wire. Perioperativly there were no major in-hospital-adverse events or complications thromboembolism, occluder dislodgement, infection or myocardial infarction. One patient had transient atrial fibrillation 2 h after implantation, which terminated medically after 12 h. TEE studies in the remaining 35 pts (one pt was unwilling to further participate) showed a residual shunt in 8.6% (3/35) after 60 days and a left-to-right shunt in 2.6% (1/35) of pts. After 180 days one pt with severe arteriosclerotic heart disease and A.carotic stenosis revealed a stroke without evidence of cardioembolic origin or devices thrombosis.
  
  
  CONCLUSIONS
  The novel Occlutech Figulla PFO N single layer device appears to be safe, feasible and useful for PFO closure despite a 50% reduction of the meshwire, no distal hub and an improved flexibility of the left atrial disc.
authors.affiliation: Clinic of Internal Medicine, Department of Cardiology, University Hospital Jena, 07747, Jena, Thuringia, Germany. Florian.Krizanic@med.uni-jena.de
authors.forename: Florian
authors.initials: F
authors.lastname: Krizanic
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Dietrich
authors.initials: D
authors.lastname: Pfeiffer
authors.forename: Thomas
authors.initials: T
authors.lastname: Konorza
authors.forename: Markus
authors.initials: M
authors.lastname: Ferrari
authors.forename: Hans-Reiner
authors.initials: HR
authors.lastname: Figulla
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys / Q000737:chemistry; D001241:Aspirin / Q000627:therapeutic use; D021721:Balloon Occlusion / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D000077144:Clopidogrel; D017548:Echocardiography, Transesophageal; D005260:Female; D005268:Femoral Vein; D005471:Fluoroscopy; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D019736:Prostheses and Implants / Q000009:adverse effects; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D000497:Alloys; D010975:Platelet Aggregation Inhibitors; C013616:nitinol; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin