Reibel I, Hauguel-Moreau M, Guedeney P, Hage G, Hammoudi N, Duthoit G, Zeitouni M, Lattuca B, Kernéis M, Collet JP, Silvain J, Montalescot G; ACTION Study Group.
Recent randomized trials have demonstrated a consistent reduction in recurrent stroke after percutaneous transcatheter patent foramen ovale closure versus medical therapy in patients with recent cryptogenic stroke.
To compare the safety and efficacy of intracardiac echocardiography-guided and microprobe transoesophageal echocardiography-guided patent foramen ovale closure under local anaesthesia with transoesophageal echocardiography-guided patent foramen ovale closure under general anaesthesia.
This prospective observational single-centre study included 194 consecutive patients scheduled for patent foramen ovale closure for secondary prevention of stroke from February 2018 to December 2019. Patients were asked to choose between an intracardiac echocardiography-guided, microprobe transoesophageal echocardiography-guided or transoesophageal echocardiography-guided procedure. The primary endpoint was the rate of successful closure at 6 months, defined as correct positioning of the device without severe shunt on 6-month contrast echocardiography.
Successful closure was high and did not differ between groups: 97.8% (95% confidence interval 88.5–99.9%) in the intracardiac echocardiography-guided group versus 96.9% (95% confidence interval 83.8–99.9%) in the microprobe transoesophageal echocardiography-guided group and 99.1% (95% confidence interval 95.3–99.9%) in the transoesophageal echocardiography-guided group (P = 0.63). Adverse events related to patent foramen ovale closure were low and did not differ between groups.
Our preliminary real-world experience suggests good efficacy and safety with intracardiac echocardiography and microprobe transoesophageal echocardiography guidance compared with conventional transoesophageal echocardiography guidance for percutaneous transcatheter patent foramen ovale closure in recurrent stroke prevention.