Transcatheter patent foramen ovale closure using the premere PFO occlusion system

Abstract

Our preliminary experience with the Premere PFO occlusion system shows that this device is safe and effective.

Premere occlusion system for transcatheter patent foramen ovale closure: Mid‐term results of a single‐center registry

“…Our single‐institution registry confirmed data of previous experience [8, 9], suggesting that Premere Occlusion System has an excellent safety profile and demonstrated a high complete closure rate also in the mid‐term follow‐up. Noticeably, the excellent safety profile is maintained in the mid‐term: no erosion and increase or new onset of atrio‐ventricular valve insufficiency [10, 11] was observed even when the device has been implanted in cases of hypertrophic or lipomatosus rims.…”

Long-term outcome of transcatheter patent foramen ovale closure in patients with paradoxical embolism

“…Our patients underwent PFO closure with APO, HPO and PPO systems. These three closure systems are reported to be the safest and most efficacious devices in terms of periprocedural complications, incidence of recurrence of neurological TE, residual shunt at follow-up and rate of thrombus formation thus underlining the importance of device design for successful percutaneous PFO closure [13,[21][22][23][24][25]. Indeed, we observe only one device embolization, no cardiac tamponade and only two patients presented coronary air embolism.…”

“…Transcatheter PFO closure has been described in detail elsewhere [12,13].The procedure was carried out under intracardiac echocardiography (ICE) (Acunav Diagnostic Ultrasound Catheter, California, USA), TEE and transthoracic (TTE) guidance. Three different types of device were used according to the availability, at different time points, including the Amplatzer PFO Occluder (APO), Helex PFO Occluder (HPO) and Premere PFO occlusion system (PPO).…”

Patent foramen ovale closure with the Intrasept occluder: Complete 6–56 months follow‐up of 247 patients after presumed paradoxical embolism

“…Results of the new Biostar occluder, the bioabsorbable version of the Starflex, are difficult to compare with our data, since residual shunting in the trial evaluating the Biostar occluder was evaluated using transthoracic echocardiography, thus potentially underestimating the degree of residual shunts [5]. Less commonly used devices such as the Premere occluder seem inferior, with a residual shunt of 36% a month following closure [6]. Closure of PFOs with radiofrequency technology without occluder placement, although intriguing, has disappointing performance data so far, with a closure rate of only 55% [19].…”