Manuscript
Severe hypoxemia secondary to COVID-19 pneumonia is a significant contributor to morbidity and mortality.1 Patent foramen ovales (PFOs) can exacerbate hypoxemia through an intracardiac shunt, slowing recovery and worsening outcomes.2-4Additionally, cryptogenic stroke is a complication commonly associated with PFOs, however, current guidelines do not address PFO management in COVID-19 patients who suffer from recurrent paradoxical emboli, especially in the setting of COVID-19 pneumonia, increased right-sided pressures, and hypercoagulable state.3, 4 This is significant considering approximately 25% - 34% of the population suffer from a congenital PFO.3, 5 Interestingly, a recent cross-sectional study (n=75) of patients under mechanical ventilation secondary to COVID-19 pneumonia found a prevalence of PFOs in 15% of their patients.6 While most patients with a PFO do not require surgical intervention, selected patients may strongly benefit from PFO closure to prevent recurrent cryptogenic strokes.7 This report describes a challenging case of an unvaccinated patient with recurrent strokes and refractory hypoxemia secondary to COVID-19 pneumonia. The patient was subsequently found to have a PFO and underwent a PFO closure using NobleStitch EL (Heartstitch, Fountain Valley, CA).
FDA approved in 2019, NobleStitch enables a deviceless method of PFO closure 8, 9 Using percutaneous access, NobleStitch approximates the septum primum and the septum secundum using two polypropylene sutures and a single polypropylene knot, thereby avoiding the risks associated with septal occluders, such as infection, anticoagulant use, arrhythmias, device erosion/dislodgment, and hindered left atrial access.8, 9 Initial registry data (n=192) has demonstrated that NobleStitch is a safe and effective method of PFO closure, revealing complete resolution of the right-to-left shunt in 75% and a grade 1 residual right-to-left shunt in 14%.9 Although recent studies have begun to refine the inclusion criteria for this procedure to improve postprocedural residual shunting, long term outcomes of this device will be better further understood with the completion of the prospective multicenter clinical trial slated to conclude in 2026.10-12