PFO- To Close for Comfort. By: Vincent J.Caracciolo, MD FACC

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1 PFO- To Close for Comfort By: Vincent J.Caracciolo, MD FACC

2 PATENT FORAMEN OVALE PFO- congenital lesion that frequently persists into adulthood ( 25-30%)- autopsy and TEE studies. PFO prevalence higher in cryptogenic stroke, especially < 55 years old. Cryptogenic Stroke- occurs in absence of cardioembolic or large vessel source with a distribution not c/w small vessel distibution. Cryptogenic stroke- 40% of all ischemic strokes in patients < 55 years old

3 PFO embryology Septum primum grows to endocardial cushions When cushions and septum primum meetperforations form this is foramen primum Perforations then fuse forming Foramen secundum ( oxygenated blood to go from RA to LA) This is effectively the Foramen ovale At birth- Flap closure- due to O2 filling alveoli cause pulm arterioles to open and decrease PVR( this increase LA pressure and reduces RA pressure)

4 Prevalence PFO ( Patent Foramen Ovale) Congenital Cardiac lesion 25-30% healthy hearts at autopsy Most are asymptomatic Stroke patients 26% had PFO found during TEE, >45 years of age Increased size of PFO in older patients

7 Other defects associated with PFO Interatrial septal Aneursym- ( ASA)- ( 0.2 to 2%) redundant mobile Interatrial septal tissue. Moves cm during cardiac-respiratory cycle- associated with PFOs Eustasian valve- juncture of IVC and RA Chiaria Network network of threads ad fibers in RA ( 2%)- strecth across RA from Eustacian valve attach to Interatrial septum

8 Inter-atrial septal aneursym

9 Atrial septal aneursym ( ASA) Increased prevalence in pts with thromboembolic CVA 8-15% 28% of CVA with normal carotid arteries Mecahnisms possible 1.) associated with PFO 2.)Fibrin- platelet particles adhere to LA side of aneursym and dislodge during ocillations

11 Eustacian Valve

12 Chiari Network

13 Cryptogenic Stroke ( CS) Absence of Cardiogenic emboli/large Vessel etiology/ distribution not c/w small vessel disease Increased risk of CS in patients with PFO Although PFO NOT associated with increased risk of RECURRENT stroke.

14 Cryptogenic Stroke

16 PFO and Stroke ( CS) Finding a PFO does NOT prove causal relationship Maybe innocent bystander ( 26% of all healthy hearts) Echo- start with transthoracic echo and then consider TEE/TCD with contrast TEE best- localize Flap Sedation may preclude adequate Valsalva- identify a PFO TCD only identify Right to left shunt shunt -not location of shunt

17 PFO and right to left shunting Can result in paradoxic embolus Transient increases in RA pressure- Valsalva Straining or Release phases- Defacate/Lifting/pushing heavy objects/ repetitive cough

18 Treatment of PFO Incidentally found PFO no follow up or treatment IF PFO is deemed causal to Cryptoigenic CVA- then medical therapy or closure of defect

19 Other clinical issues with PFO Migraine headache Decompression sickness Platypnea/orthodeoxia syndrome

20 WHAT is the DATA Isolated PFO- NOT associated with recurrent stroke Case Control Studies/meta analysis of them Increased risk of CVA if PFO, ASA or both in patients < 55 years old Odds ratio 3.1, 6.1, 15.6 Retrospective data risk of PFO and initial likelyhood of CVA History of Straining/hypercoaguable state/ multiple CVAs, Large PFO, Large right to left shunt, Spontaneous R to L shunt, PFO Flap mobility Another study showed no recurrent CVAs in a similar

21 Restrospective data Retrospective data PFO and initial risk of CVA History of Straining hypercoaguable state/ multiple CVAs Large PFO, Large right to left shunt, Spontaneous R to L shunt, PFO Flap mobility Prominent Eustasian valve or Chiari network Presence of Atrial Septal Aneursym

22 Prospective Studies Variable results French PFO- ASA study- 581 pts PICSS study- 630 pts CODICIA study- 486 patients NOMAS Study pts SPARC study

23 French PFO- ASA Study- 581 pts ( case control) < 55 years old ( mean 42) with Cryptogenic stroke 37% had PFO 1.7% had ASA 8.8% had both PFO and ASA All pts got Aspirin 300 mg a day Isolated ASA group at 4 years no recurrence of CVA Isolated PFO group-( regardless of size) no CVA at 4 years Both PFO and ASA- increased risk of CVA ( 15% vs 4% in the absence of these abnormalities

24 PICSS sudy- 630 pts- Ischemic CVA 42% were Cryptogenic CVA (case control) TEE showed that the CS patients higher incidence of PFO- 39% vs. 29% average age- 59 years old Assigned to receive ASA 325 mg a day vs warfarin for INR No association between PFO alone or PFO and ASA and recurrent risk of CVA or death ( different from French study) No reduction of recurrent CVA in pts on Warfarin vs. Aspirin

25 CODICIA study- 486 pts ( prospective) Transcranial Doppler quantify the magnitude of Right to left shunt- (RLSh) 2 year follow up, < 55 years old No association between magnitude of (RLSh) and recurrent CVA whether or not a Atrial Setpum aneursym was found or not

26 NOMAS STUDY 1100 patients (Prosepctive) Stroke free pts, > 40 years old Manhattan NY( mean age 69)- followed for about 6 years ( 80 months) TTE used to detect PFO PFO found in 14.9% patients ASA- 2.5% of pts. PFO alone or with ASA- statistically non-significant minor increased risk of CVA

27 SPARC study- 588 pts ( prosepctive) >45 years old, Olmstead Minnesoata- follow up- 5 years Used TEE- found 24% had PFO, 1.9% ASA PFO not significant risk for CVA after adjustment for comorbidities PFO size not associated with risk of CVA ASA 4 fold increase increase ( statistically not significant) only 11 pts had an ASA

28 Conclusions True risk of primary or recurrent ischemic Stroke associated with PFO or ASA difficult to estimate Case Control Trials- Association between Cryptogenic stroke and PFO- However 1/3 of all PFO found in Cryptogenic CVA are likely to be incidental findings Prospective trials PFO not associated with increased risk of recurrent CVA PFO + ASA- increased risk in French PFO/ASA study but not PICSS or CODICIA studies

29 2011 AHA/ASA guidelines PFO +/- ASA uncertain clinical importance in the development of first or recurrent CVA

30 Treatment for PFO/ASD and ASA for prevention of CVA 2011 AHA/ASA antiplatelet therapy is reasonable for cryptogenic CVA where no anticoagulation is necessary ( hypercoaguable patients) French PFO study- 216 pts with cryptogenic CVA + PFO Risk of recurrent CVA- 2.3% on Aspirin 300 mg qd Risk of recurrent CVA was 4.2% without PFO PFO + ASA- recurrent CVA- 15.2%- possible Warfarin or closure

31 PFO closure ( percutaneous vs surgical) No data on efficacy of closure on recurrent CVA Surgical closure- recurrent risk of CVA- 7-14% Sometimes residual shunt persists despite closure Lateral LA wall thrombus Increased atrial arrythmias with closure device

33 PC trial ( Amplatzer PFO occluder device) 414 pts (CS + PFO)-- < 60 year old PFO closure trials ( prospective/intention to treat) Closure 1 ( Starflex device) RESPECT 980 pts ( Amplatzer) ( CS + PFO_ = avg age- 46 years old 5 CVA vs 16 in the medical arm No statistically significant reduction in death/cva/tia When using intention to treat analyses but using raw data analysis it met statistical significance in CVA reduction alone ( p <.007%)

34 Starflex device

35 Amplatzer Septal Occluder device

36 TIA- 3.1 vs 4.1 % Closure 1 Trial Pts <60 with PFO + CS or TIA PFO closure (n= 447) vs med Rx (n= 462) Staflex PFO closure devise + ASA/Plavix x 6 months then ASA alone Med Rx- ASA or warfarin or both Endpoint CVA or TIA at 2 years No differences Combo of CVA/TIA ( 5.5 vs 6.8%) CVA- 2.9 vs 3.1%

37 Closure 1---subgroups Shunt size-- no differences in recurrent CVA ASA-- no differences Afib increased in PFO device arm 5.7% vs. 0% 5 of 12 strokes in Device arm- device thrombosis or afib related--??? Another devise could do better Critics feel study was underpowered and 2 year f/u not long enough ( i.e the CEA trials did not show benefit at 2 years) Suspicion that highest risk pts had closure outside the study

38 2012 ACCP guidelines Asymptomatic PFO or ASA NO antithrombotic therapy Incidental PFO and surgical closure may increase risk of post-op CVA PFO +/- ASA with cryptogenic CVA Aspirin If recurrent CVA on Aspirin or PFO + DVT then warfarin x 3 months then device closure vs. Aspirin

39 PFO with ASA (? Closure) French PFO/ASA study 51 pts ( < 55 years old) with Cryptogenic Stroke Recurrent CVA- 15.2% ( PFO+ ASA) on Aspirin Rx Suggest more aggresive therapy with Warfarin or closure BUT no difference in outcomes in the PICCS trial

I, (Issam Moussa) DO NOT have a financial interest/arrangement t/ t or affiliation with one or more organizations that could be perceived as a real

I, (Issam Moussa) DO NOT have a financial interest/arrangement t/ t or affiliation with one or more organizations that could be perceived as a real PFO Closure: Where We Are Going to after CLOSURE I Study? Issam D. Moussa, MD Professor of Medicine Chair, Division of Cardiovascular Diseases Mayo Clinic Jacksonville, Florida Disclosure Statement of