Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS).


BACKGROUND
There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS.


METHODS
We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up.


RESULTS
PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001).


CONCLUSIONS
PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy.
Thanopoulos
Basil Vasilios D
BV
Department of Cardiology, Aghia Sophia Children's Hospital, Athens, Greece. vthanop@otenet.gr
Dardas
Petros D
PD
Karanasios
Evangelos
E
Mezilis
Nicholaos
N
D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects; D004621:Embolization, Therapeutic / Q000009:adverse effects / Q000295:instrumentation; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000150:complications* / Q000628:therapy*; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D019736:Prostheses and Implants; D012107:Research Design; D055502:Secondary Prevention; D020521:Stroke / Q000209:etiology* / Q000517:prevention & control*; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors