Appeal type: Experimental/Investigational
Decision: Upheld

Reviewer #2

Diagnosis: Patent foramen ovale (PFO)

Treatment: Heart surgery (transcatheter closure of patent foramen ovale; procedure code 93580)

The insurer denied coverage for heart surgery (transcatheter closure of patent foramen ovale; procedure code 93580). The denial is upheld.

The patient was seen, as an outpatient, by a cardiologist for consideration of closure of a patent foramen ovale (PFO) in the setting of a cryptogenic stroke.  The patient's list of medical problems included cerebrovascular accident (CVA), hypertension, type II diabetes, atrial septal defect, transient ischemic attack (TIA) and unspecified stenosis of the coronary arteries and status post left carotid endarterectomy (CEA).  The History of Present Illness (HPI) described the patient as a male with two prior TIA events.  At that time, the patient was found to have significant left carotid artery stenosis and underwent left CEA.  The patient's echocardiogram at the time was reportedly normal with no intra-cardiac shunts as a possible cause.  Also, there were no underlying atrial arrhythmias that may have caused these events.  The patient's recent transcranial Doppler ultrasound revealed a grade 1 small PFO.  Given the history of two TIA events in the setting of this grade 1 suspected PFO, the patient was referred for possible PFO closure.  

The patient's family history was significant for both parents having undergone cardiac bypass surgery.  The patient was not a cigarette smoker.  The patient's home medications included irbesartan, amlodipine, aspirin, atorvastatin, insulin, metformin and Glucophage.  There were no abnormalities described in his physical examination.  The patient's electrocardiogram (EKG) revealed: sinus rhythm at 67 bpm with ventricular premature beats and left anterior fascicular block.  The patient's positron emission tomography (PET) scan done showed no perfusion defects.  The patient's echocardiogram done revealed normal ejection fraction.  The patient's transcranial Doppler done revealed a grade 1 PFO.  The patient's cardiac monitoring done revealed no abnormal arrhythmias.  The patient's cardiologist recommended closure of the PFO with the noble heart stitch.  A patient's transcranial Doppler revealed a positive right to left shunt at rest and with Valsalva with grade 1; there was no increase with Valsalva.  

There have been five, large, randomized controlled trials testing whether mechanical closure of a patent foramen ovale (PFO) among patients with prior cryptogenic stroke could reduce the rate of recurrent stroke.  Three reports, published between 2003 and 2016, were positive, [1-3] and three, published between 2000 and 2011, were negative. [4-6]  While some in the cardiology community have argued that PFO closure is good as a "mechanical vaccination" against stroke, other authors try to reconcile the divergent conclusions of these six trials.[7]  It has been suggested that caution is warranted in the extrapolation of this data and the application of this intervention to broader patient groups.

Based on the review of the medical record, this patient had a history of transient ischemic attack (TIA) and cerebrovascular accident (CVA), and a past medical history which included hypertension and diabetes mellitus type II.  Though this patient had significant risk factors for cerebrovascular disease, this patient's small PFO was not likely to be related.  The patient was on aspirin therapy but has not taken the newer anticoagulant agents.  Thus, the use of PFO closure is not likely to be more beneficial than any of the standard treatments/procedures for this patient.

The carrier's denial of coverage for heart surgery (transcatheter closure of patent foramen ovale; procedure code 93580) should be upheld.