Effectiveness and safety of MemoPart for patent foramen ovale closure in real-world patients

Patent foramen ovale (PFO) is a common congenital heart defect associated with cryptogenic stroke, transient ischemic attacks (TIAs), and migraines. The Multifenestrated MemoPart device is specifically designed to address complex anatomical variations of PFO. This study evaluates the feasibility, safety, and effectiveness of MemoPart for PFO closure in a real-world setting.

Consecutive patients undergoing PFO closure with the MemoPart device were included. Diagnosis was based on transthoracic echocardiography with bubble contrast and quantification of Valsalva maneuver intensity with a Valsalva assist device. Procedural success, adverse events, residual shunts, and clinical outcomes were assessed at baseline and up to 3 months.

A total of 60 patients were included in the overall analysis, with age 51.6±12.6 years, and 30 (50%) women. Most participants (46 [77%]) reported a history of stroke, and a Reduce PFO morphology was the most common (34 [57%]). Acutely complete closure was achieved in 59 (98% [91%-100%]) cases, whereas 3-month echocardiographic follow-up showed complete closure in all 60 (100% [94%-100%]). No major or other serious adverse events were reported, and bubble testing showed 0 MES in 49 (82% [70%-91%]) cases. Exploratory ordinal logistic regression suggested that MES were higher in those with complicated (natural logarithm of the odds ratio [LnOR]=1.54 [0.04-3.04], P=0.044) and Tunnel morphologies (LnOR=1.23 [0.01-2.45], P=0.048), as well as with atrial septal aneurysm (LnOR=2.22 [0.54-3.91], P=0.010).

MemoPart is a safe and effective option for PFO closure, in routine as well as anatomically complex cases. These findings support its routine use and encourage further long-term studies to confirm its clinical benefits.