Clinical evaluation of a novel occluder device (Occlutech) for percutaneous transcatheter closure of patent foramen ovale (PFO).
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.
Krizanic
Florian
F
Clinic of Internal Medicine, Department of Cardiology, University Hospital Jena, 07747, Jena, Thuringia, Germany. Florian.Krizanic@med.uni-jena.de
Sievert
Horst
H
Pfeiffer
Dietrich
D
Konorza
Thomas
T
Ferrari
Markus
M
Figulla
Hans-Reiner
HR
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
D000497:Alloys; D010975:Platelet Aggregation Inhibitors; C013616:nitinol; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin