January 16, 2004Open Access
Percutaneous closure of patent foramen ovale: impact of device design on safety and efficacy
Key Result
Percutaneous PFO closure with the Amplatzer occluder had fewer procedural complications (2% vs 16%, P=0.01) and less residual shunt (6% vs 34%, P=0.004) than the STAR device.
Study Design
Type
Cohort (n=100)
Structured PICO
Does the Amplatzer PFO occluder reduce procedural complications and residual shunt compared to the PFO STAR device in patients with presumed paradoxical embolism?
P
Population
100 consecutive patients with presumed paradoxical embolism undergoing percutaneous PFO closure with the STAR or Amplatzer devices, followed for up to 3.5 years.
E
Exposure
Percutaneous closure of patent foramen ovale (PFO) with the Amplatzer PFO occluder (n=50).
C
Comparator
Percutaneous closure of PFO with the PFO STAR device (n=50).
O
Outcome
Procedural complications, residual shunt at 6 months (assessed by transoesophageal contrast echocardiography), and recurrence of thromboembolic events.
The Amplatzer PFO occluder is associated with fewer procedural complications and lower rates of residual shunt compared to the PFO STAR device for percutaneous PFO closure.
Main Result
Absolute Event Rate: 2% vs 16%
p-value: p=0.01
Abstract
OBJECTIVE: To compare the safety and efficacy of percutaneous closure of patent foramen ovale (PFO) with the Amplatzer PFO occluder (Amplatzer) or the PFO STAR device (STAR) in patients with presumed paradoxical embolism. METHODS: Implantation characteristics, procedural complications, residual shunt, and recurrence of thromboembolic events were recorded prospectively in 100 consecutive patients undergoing percutaneous PFO closure with the STAR (n = 50) or Amplatzer (n = 50) devices between 1998 and 2001. The study was not randomised. Device implantation was successful in all cases. RESULTS: There were more procedural complications in the STAR than in the Amplatzer group (8/50 v 1/50, p = 0.01). More than one device placement attempt was an independent predictor of procedural complications (odds ratio (OR) 8.5, 95% confidence interval (CI) 1.3 to 55.8; p = 0.03). A residual shunt six months after PFO closure, assessed by transoesophageal contrast echocardiography, occurred more often in the STAR than the Amplatzer group (17/50 v 3/50, p = 0.004), and was predicted in the STAR group by the use of a device with a 5 mm as opposed to a 3 mm disc connector (OR 6.1, 95% CI 1.1 to 34.0; p = 0.04). The actuarial risk of recurrent thromboembolic events after 3.5 years was 16.8% (95% CI 7.6% to 34.6%) in the STAR and 2.7% (95% CI 0.4% to 17.7%) in the Amplatzer group after three years (p = 0.08). CONCLUSIONS: Percutaneous PFO closure with the Amplatzer PFO occluder had fewer procedural complications and was more likely to be complete than with the STAR device. These findings underline the importance of device design for successful percutaneous PFO closure.