PFO business NEJM September 14,2017
article 1- Farb A, Ibrahim BG, Zuckerman BD. Patent foramen ovale after cryptogenic stroke --assessing the evidence for closure NEJM 2017: 377: 11 pp. 2006-2009.
article 2- Mas J-l, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. NEJM 2017: 377: 11 pp.1011-1021. 663 patients were randomized 1:1:1. Average ROPE score was 7, selected group had large shunt without ASA or with ASA, or had a mild to moderate shunt and ASA.
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
Article 3: Saver, JL, Carroll JD, Thaler DE et al. Long term outcomes of patent foramen ovale closure or medical therapy after stroke. NEJM 2017: 377: 11 pp.1022-1032. They studied 960 patients with PFO and cryptogenic stroke ages 19-60; extension trial of previously reported NEGATIVE RESPECT trial at two years. Subjects had to have TEE confirmed PFO with exclusion of large artery arteriopathy, lacune, known cardioembolic source, dissection, APL AB'sASCOD or other known cause of stroke.ASCOD method was used to determineAbout one third had hypertension, 7-8 percent smoked, 6-8 percent had DM. In stroke v. medical therapy, there were 0.58 percent and 1.07 events per 100 patient years
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">Article Four Sandergaard L, Kasner SE, Rhodes JF. et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. NEJM 2017: 377: 11 pp. 1033-42. International trial studied PFO closure + antiplatelet to antiplatelet therapy only. 664 patients were enrolled. Median followup was 3.2 years. 1.6 percent had serious device related complications and 6.6 percent had postprocedure atrial fibrillation. Subjects needed to be less than 60, and OTHER causes of stroke had to be ruled out as above to be enrolled. They all had imaging of arteries of head and neck and aortic arch.Holter monitoring not required. ASA was only assessed at timeof closure. Clinically known infarcts were reduced but silent infarcts were not.There was a 1.4 v 5.4 percent difference in amount of new strokes.
Editorial, Ropper A. Tipping point for PFO. Notes importance of cardiac criteria (large shunt, presence of ASA) as well as clinical criteria (ROPE score). A large PFO is defined as a more than thirty microbubbles in three cardiac cycles; a large ASA is septum primum excursion more than 10 mm.
my editorial notes Statistical benefit is undeniable in patients under 60, with a RoPE score of seven or more, with an ASA, with cryptogenic stroke after full evaluation. Parsing those patients with partial combinations of features will still be challenging. Clinical degree of benefit is small number with NTT around 20 and the amount of side effects around five percent. Questions going forward, include: can one screen for right to left shunt with TCD rather than TEE; more precise criteria involving clinical and cardiac features of PFO. Also, what amount of cardiac eval for atrial fibrillation needs to be done in cryptogenic patients prior to closing. In studies, 30 days was enough, but other studies suggest a need for much longer monitoring in which case, if positive, the strokes are not cryptogenic.
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
article 1- Farb A, Ibrahim BG, Zuckerman BD. Patent foramen ovale after cryptogenic stroke --assessing the evidence for closure NEJM 2017: 377: 11 pp. 2006-2009.
article 2- Mas J-l, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. NEJM 2017: 377: 11 pp.1011-1021. 663 patients were randomized 1:1:1. Average ROPE score was 7, selected group had large shunt without ASA or with ASA, or had a mild to moderate shunt and ASA.
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
Article 3: Saver, JL, Carroll JD, Thaler DE et al. Long term outcomes of patent foramen ovale closure or medical therapy after stroke. NEJM 2017: 377: 11 pp.1022-1032. They studied 960 patients with PFO and cryptogenic stroke ages 19-60; extension trial of previously reported NEGATIVE RESPECT trial at two years. Subjects had to have TEE confirmed PFO with exclusion of large artery arteriopathy, lacune, known cardioembolic source, dissection, APL AB'sASCOD or other known cause of stroke.ASCOD method was used to determineAbout one third had hypertension, 7-8 percent smoked, 6-8 percent had DM. In stroke v. medical therapy, there were 0.58 percent and 1.07 events per 100 patient years
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">Article Four Sandergaard L, Kasner SE, Rhodes JF. et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. NEJM 2017: 377: 11 pp. 1033-42. International trial studied PFO closure + antiplatelet to antiplatelet therapy only. 664 patients were enrolled. Median followup was 3.2 years. 1.6 percent had serious device related complications and 6.6 percent had postprocedure atrial fibrillation. Subjects needed to be less than 60, and OTHER causes of stroke had to be ruled out as above to be enrolled. They all had imaging of arteries of head and neck and aortic arch.Holter monitoring not required. ASA was only assessed at timeof closure. Clinically known infarcts were reduced but silent infarcts were not.There was a 1.4 v 5.4 percent difference in amount of new strokes.
Editorial, Ropper A. Tipping point for PFO. Notes importance of cardiac criteria (large shunt, presence of ASA) as well as clinical criteria (ROPE score). A large PFO is defined as a more than thirty microbubbles in three cardiac cycles; a large ASA is septum primum excursion more than 10 mm.
my editorial notes Statistical benefit is undeniable in patients under 60, with a RoPE score of seven or more, with an ASA, with cryptogenic stroke after full evaluation. Parsing those patients with partial combinations of features will still be challenging. Clinical degree of benefit is small number with NTT around 20 and the amount of side effects around five percent. Questions going forward, include: can one screen for right to left shunt with TCD rather than TEE; more precise criteria involving clinical and cardiac features of PFO. Also, what amount of cardiac eval for atrial fibrillation needs to be done in cryptogenic patients prior to closing. In studies, 30 days was enough, but other studies suggest a need for much longer monitoring in which case, if positive, the strokes are not cryptogenic.
<60 .="" 1-4="" 12-15="" 29="" 2="" 5.4="" 5.9="" 8-11="" at="" atrial="" be="" cause="" chol.="" complications="" cryptogenic="" developed="" did="" dm="" fibrillation="" five="" followup="" found="" four="" had="" high="" htn="" ie="" including="" mean="" nbsp="" no="" not="" number="" one="" or="" other="" over="" p="" percent="" prevent="" procedure.="" recur="" smokers="" stroke="" that="" to="" transient="" treat="" twenty.="" unsuccessful="" usually="" was="" were="" years.="" years:="" years="">
