Feasibility, efficacy and safety of PFO closure under local anesthesia with transoesophageal echocardiography microprobe: A single-center study of 383 patients

Percutaneous patent foramen ovale (PFO) closure is usually performed under general anesthesia (GA) with guidance by transesophageal echocardiograpy (TEE). Microrobe makes this procedure possible under local anesthesia (LA). Our study aimed to assess the feasibility, efficacy and safety of PFO closure under LA with microprobe guidance. The aim was to evaluate the rate of PFO closure failure in patients who underwent a procedure under LA with a TEE microprobe (micro-LA group) vs. under GA with a conventional probe (conventional-GA group). The primary endpoint was the persistence of inter-atrial shunt (> 10 microbubbles) 6 months after procedure, screened by contrast transthoracic ultrasound. The secondary objectives were: identification of risk markers for the persistence of inter-atrial shunt at 6 months, post-procedure complication rates and major cardiovascular events rate. Three hundred and eighty three patients were included: 303 (79%) in the conventional-GA group, 79 (21%) in the micro-AL group. The median follow-up was 28.0 (14.0–49.0) months. The average age was 49.9 ± 12.6 years, 61.9% of men. There was no failure of PFO closure under AL. Six months after PFO closure, there was no difference in persistence of inter-atrial shunt between the conventional-GA group and the micro-AL group (29.3% vs. 25.5%, P = 0.583). There was no difference in the occurrence of complications related to the procedure between the 2 groups. In multivariate analysis, the presence of interatrial septal aneurysm [OR 1.88 (95% CI 1.07–3.31), P = 0.029], ROPE score > 6 [OR 1.22 (1.04–1.43), P = 0.015] and the occurrence of stroke following the procedure [OR 4.48 (1.12–17.87), P = 0.034] were independently associated with the presence of a residual inter-atrial shunt at 6 months. Our study identified that PFO closure under LA with TEE microprobe is feasible and safe. There was no difference in efficacy of 6-month FOP closure, regardless of conventional-GA or micro-AL method.