Premere occlusion system for transcatheter patent foramen ovale closure: mid-term results of a single-center registry.
BACKGROUND
Transcatheter closure of patent foramen ovale (PFO) with rigid devices may be problematic in patients with long channel PFO: alternative devices with asymmetrical opening and more physiological positioning may be preferable in such cases. We present the mid-term results of transcatheter closure of PFO with Premere Occlusion System, a device studied for this specific anatomy, in a single-center registry of adults with previous cerebral ischemia.


METHODS
During a 53-months period (July 1, 2005 to December 1, 2009) 70 patients (48 females and 22 males, mean age 38 ± 6.7 years) with previous stroke were admitted in our center for transcatheter closure of PFO with Premere Occlusion System on the basis of absence of moderate or severe atrial septal aneurysm (ASA) on Transesophageal echocardiography and intracardiac echocardiography (< 3RL or 3LR ASA and length of PFO channel >10 mm).


RESULTS
The procedure was successful in all of the patients with no peri-operative and in-hospital complications. Forty-six 20 mm and twenty-four 25 mm Premere devices were implanted. Rates of procedural success, predischarge occlusion, and complication were: 100%, 95.7% and 0%, respectively. On mean follow-up of 40 ± 10.9 months (range 6-54), the follow-up occlusion rate was 98.5%. During follow-up, no cases of permanent atrial fibrillation, aortic/atrial erosion, device thrombosis, or atrioventricular valve inferences were noted.


CONCLUSIONS
The mid-term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long-channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims.
Rigatelli
Gianluca
G
Section of Adult Congenital Heart Disease Interventions, Cardiovascular Diagnosis and Interventions Service, Rovigo General Hospital, Rovigo, Italy. jackyheart@libero.it
Cardaioli
Paolo
P
Dell'avvocata
Fabio
F
Giordan
Massimo
M
Chinaglia
Mauro
M
D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D004867:Equipment Design; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology; D007558:Italy; D008297:Male; D015641:Radiography, Interventional; D012042:Registries; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome