New bioabsorbable septal repair implant for percutaneous closure of a patent foramen ovale: short-term results of a single-centre experience.
BACKGROUND
Permanent implants for closure of a patent foramen ovale (PFO) have a number of possible disadvantages including erosions, thrombus formation, and allergic reactions. The incidence of adverse events may be lower using a bioabsorbable device.


OBJECTIVE
To evaluate the short-term safety and efficacy of a new bioabsorbable closure device.


METHODS
All 35 consecutive patients (21 female, mean age 47.9 +/- 10.8 years), who underwent a percutaneous PFO closure between November 2007 and July 2008, were included. All complications were reported. The efficacy was based on the residual shunting the day after implant and at 1 month follow-up and was graded as minimal, moderate, or severe, using contrast transthoracic echocardiography with the Valsalva manoeuvre.


RESULTS
The only in-hospital complication was a surgical device retrieval from the femoral vein. Four patients developed a minimal inguinal haematoma. One day after closure, residual shunting was present in 56% of the patients (minimal 27%, moderate 23% and severe 6%). At 1 month follow-up (n = 33), one patient developed a transient neurological deficit and three patients suffered from paroxysmal atrial fibrillation. A residual shunt at 1 month was present in 45% of the patients (minimal 30%, moderate 12%, and severe 3%).


CONCLUSIONS
Percutaneous PFO closure using the bioabsorbable closure device seems to be safe. However, a high rate of residual shunting is present at 1 month follow-up. Long-term follow-up data are necessary to evaluate the efficacy and safety of this device.
Van den Branden
B J L
BJ
Department of Cardiology, St. Antonius Hospital, Nieuwegein, The Netherlands.
Post
M C
MC
Jaarsma
W
W
ten Berg
J M
JM
Suttorp
M J
MJ
D020341:Absorbable Implants; D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D003287:Contrast Media; D003326:Coronary Circulation; D017548:Echocardiography, Transesophageal / Q000379:methods; D004867:Equipment Design; D005260:Female; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome; D014636:Valsalva Maneuver
D003287:Contrast Media