Makindo Medical Notes"One small step for man, one large step for Makindo" |
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Related Subjects: |Congenital Acyanotic Heart Disease |Congenital Cyanotic Heart Disease |Cardiac Embryology |Cyanosis - Central and Peripheral |Down's syndrome (Trisomy 21) |Tetralogy of Fallot |Patent Foramen Ovale (PFO)
Reference | Outcome | N | Events in treatment arm | Events in Compared group | Significance |
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2017 | |||||
Sondergaard L et al. PFO closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med 2017;377:1033-1042 | Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischaemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. | N=664 (mean age, 45.2 years) of whom 81% had moderate or large interatrial shunts for 3.2 years | AIS 6 of 441 patients (1.4%) in PFO closure group over 3.2 years. New Brain infarction 22 patients [5.7%] | AIS in 12 of 223 patients (5.4%) in antiplatelet-only group over 3.2 years. New Brian infarction 20 patients [11.3%] | Significant reduction of stroke and new brain infarction. However silent brain infarction did not differ significantly. Increased risk of AF in 6.6% after PFO and some device related complications |
Mas J-L et al. PFO closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med 2017;377:1011-1021 | No stroke in 238 patients in the PFO closure group, vs 14/235 patients in the antiplatelet-only group (P<0.001). Procedural complications in 14 patients (5.9%). The rate of AF higher in the PFO closure group. | N= 663 patients for 5.3 2.0 years | Zero strokes/238 patients in PFO closure group. AF in 4.6% | Stroke in 14 of the 235 patients in antiplatelet-only group. AF in 0.9% | Significant reduction in stroke in those with PFO closure but an increase in AF and procedural complications |
Saver JL et al. PFO closure or medical therapy after stroke. N Engl J Med 2017;377:1022-1032 | Among adults who had had a cryptogenic ischaemic stroke, closure of a PFO was associated with a lower rate of recurrent ischaemic strokes than medical therapy alone during extended follow-up. | N= 980 patients x 5.9 years | AIS 18/3141 patient years (0.58 events/100 yrs.) 10 patients | AIS 28/2669 patients years (1.07 events/100 yrs.) 23 patients | Reduction in stroke in PFO group as p =0.046 by the log-rank test. VTE commoner in PFO group. |
Comments on data seem to show that the risks of subsequent stroke in this population is actually very small and seems to be less than 1% per annum. It would not take many closure device AF related strokes to cancel out the benefits which are relatively significant but absolutely not massive.
It is clear that patient selection is key. Do not assume that the only cause of a cryptogenic stroke is a found PFO. Make sure first that the pattern of stroke symptoms and findings does support a cardioembolic aetiology. The various PFO closure trials have shown mixed results. Some showed that PFO closure made no difference and others that stroke events were significantly reduced by closing a PFO. variable numbers of patients still had strokes after PFO closure but in several newer trials it was less than the small number who had strokes in the non-closure groups. PFO closure reduces risk but does not eliminate it. However, the ones who had further stroke either had another cause, had a PFO closure or they simply had undiagnosed PAF or some other cause. I have to say it is difficult to know what one would want for oneself and I suspect that as human nature likes doing things then most of us now would opt for closure once all other issues had been resolved. Doctors find it easier to justify action than inaction. The reality is the long-term consequences of these devices is unknown and the aim of the device is to make a small absolute risk smaller. Whether the benefits continue later in life is unknown. There is no real long-term data. We just don't know, and we have to ensure that we discuss the uncertainties with the patient and lower expectation that this procedure possibly may or may not prevent further strokes. The risk of further stroke does seem to be small. Eliminating one possible cause of stroke also does not prevent the many others. The risks of the procedure need to be borne in mind. One should never operate on the heart without a clear understanding of future benefits.
I find this very challenging as one has to try and educate the patient about the uncertainty. I think everyone agrees that not all PFOs need closing but which specific ones to close and which to leave alone is difficult. The following points should be made to anyone who is being considered for PFO closure for cryptogenic stroke. There should hardly ever be the assumption that the presence of a PFO shows causation that is 100% strong. Remember there are other mechanism going on which can cause cryptogenic stroke such as PAF. Closing a PFO is unlikely to help PAF. A PFO may be a surrogate marker for PAF or something else we don't fully understand and so closing the hole for many may be irrelevant. The discussion with the patient by stroke physician or cardiologist should cover these points. There should a clear discussion between both as to the merits and an agreed line with the acknowledgement of much uncertainty. Remember there are two parallel prongs to preventing PFO related stroke and these are A) Preventing venous thrombosis i.e. DVT and B) Occluding the Hole.
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