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Low rate of complications found with three PFO closure devices
A randomized trial has found low rates of procedural and long-term complications with three patent foramen ovale closure devices. Of note, a significantly lower rate of recurrent neurological events was reported in patients receiving the Amplatzer device.
The study, which was published recently in the European Heart Journal, examined 660 patients with cryptogenic stroke who were randomly assigned to three different PFO closure devices — Amplatzer (AGA Medical; n=220), CardioSEAL-STARflex (NMT Medical; n=220) and the Helex occluder (W.L. Gore; n=220) — from January 2001 to December 2004.
Technical success with device implantation was achieved in all cases. Researchers reported pericardial tamponade requiring surgery in one patient (Amplatzer group); device embolization in three patients (all Helex group); and thrombus formation on the device in 12 patients (CardioSEAL-STARflex, n=11; Helex, n=1), two of which required surgery. They also found that complete closure after device implantation was more common with the Amplatzer (98.6%) and CardioSEAL-STARflex (96.8%) devices than with the Helex occluder (91.8%; P=.0012).
Five years after the procedure, the study’s primary endpoint — recurrent cerebral ischemia (stroke, transient ischemic attacks or Amaurosis fugax), death from a neurological cause or any other paradoxical embolism — occurred in 25 patients. Of these events, significantly fewer were reported in the Amplatzer group (1.4%; two strokes and one ischemic death) compared with the CardioSEAL-STARflex (6%; six TIAs, six strokes and one cerebral death) and Helex (4%; four TIAs, four strokes and one cerebral death; P=.04) groups.
The rate of stroke and death did not differ significantly between the three groups (P=.5827).
As a result of the findings, the researchers concluded that PFO closure is safe.
“However, there appear to be significant differences in the neurological event rate between devices,” they wrote. “Hence, the choice of device may determine the efficacy of PFO closure. This has important implications for future PFO trial designs and interpretation.”
Disclosure: Hornung reports no relevant financial disclosures.