The Rationale for PFO Closure: A Series of Arguments For or Against
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Abstract
During the last decade, patent foramen ovale (PFO) and intermittent or permanent right-to-left shunting of venous blood has been proposed to play a pathogenetic role in a number of disorders. This review covers the most common and sometimes controversial indications for closure of the PFO. It considers the safety of the procedure, current evidence that supports closure, and counter arguments. It then offers a considered position for each indication.
Introduction
In recent years, there has been a great deal of attention paid to the patent foramen ovale (PFO). In particular, many have accused it of being responsible for a number of complex conditions, such as cryptogenic stroke and migraine.1,2 Figures 1–3 illustrate the anatomy of a PFO. Figure 1 depicts the normal situation where the PFO remains closed. Figure 2 shows the effect of a temporary increase in right atrial pressure above that in the left atrium, causing the PFO to open, permitting “right-to-left shunting.” Figure 3 shows a porcine PFO viewed from the left atrial side, clearly depicting the PFO as a track or tunnel. For the majority, PFO will remain asymptomatic with no major risk of complications. It is for that reason that PFOs are not systematically closed when detected. However, it is the most common defect diagnosed in young patients that present with an unexplained cerebrovascular event; it is present in about 50% of migraine-with-aura (MA) patients and in patients suffering from cryptogenic stroke; divers with a PFO are 4.5 times more likely to experience decompression sickness than those without a PFO;4 it is four times more prevalent in individuals who are susceptible to high-altitude pulmonary edema than in those who are not; and it may be the cause of right-to-left shunting that is responsible for various other forms of hypoxia/hypoxemia. PFO would, therefore, seem to be implicated in a number of medical conditions. In this article, we seek to elucidate the role that the PFO may play in these conditions by referencing literature. We will also consider any circumstances that could justify closure of the PFO.
PFO Closure Ccomplications
Before we decide if PFO closure is an appropriate therapy for our patient, we should be aware of the risks. In a review of literature, Khairy5 found an incidence of 7.9% and 1.5% of minor and major complications, respectively, in relation to device closure. We have found that in some of the earlier reports of PFO closure, complication rates varied significantly and were often associated with device designs that may have been superseded. In a more recent report6 of a randomized trial comparing Amplatzer (AGA Medical Corporation, Plymouth, Minnesota), CardioSEAL-STARFlex (NMT Medical, Inc., Boston, Massachusetts), and Helex (W.L. Gore and Associates, Flagstaff, Arizona) devices, complication rates were not insignificant. Each of the 3 devices gave rise to episodes of atrial fibrillation (1.4%, 0.9%, and 0.9%, respectively). Just over half of these resolved spontaneously; the remainder required the use of antiarrhythmics. Device embolization, hemopericardium, and transient ischemic attack (TIA) occurred with the Helex device (1.4%, 0.5% and 0.5%, respectively); pericardial tamponade necessitating surgical removal, fever, and peripheral vein thrombosis occurred with the Amplatzer device (0.5%, 0.9% and 0.5%, respectively); and thrombus on the device, paroxysmal supraventricular tachycardia, and fever occurred with the CardioSEAL-STARFlex device (3.6%, 0.5% and 0.5%, respectively). Furthermore, two CardioSEAL-STARFlex devices needed to be removed through auxiliary vascular access because of unsatisfactory positioning. Less serious complications relating to the anticoagulant medication were also reported for the Amplatzer and Helex devices — both at 4.5%. Moderate to severe residual shunt rates at 30 days were 4.1%, 5.5%, and 11.4% for the Amplatzer, CardioSEAL-STARFlex, and Helex devices, respectively. Complications are listed in Table 1.
This report does show that the PFO closure procedure is not without risk and that it may not wholly resolve shunting. It is necessary to consider the risk-to-benefit ratio when deciding on the appropriate therapy for the patient.
Anatomical features such as Chiari network or prominent eustachian valve may also need to be considered before deciding if closure is appropriate. Such features, in combination with PFO, seem to increase the risk of paradoxical embolism.7–9 They may contribute to MA9 and affect optimal closure device positioning. As technology evolves, devices hopefully become safer relative to the risk of complications.
PFO and Cryptogenic Stroke
An ischemic stroke is classified as cryptogenic if no cause can be defined following an adequate diagnostic evaluation. The basis of such an evaluation was used to classify stroke sub-types in a study of low molecular weight heparin and has become known as the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) classification.10
Prevalence of cryptogenic stroke. Findings published from the National Institute of Neurological and Communicative Disorders databank showed that the prevalence of cryptogenic stroke in a population < 60 years is 30–40% of the total stroke and TIA population.11
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