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PFO CLOSURE

PFO CLOSURE. JOURNAL REVIEW OF EVIDENCE. Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984;59:17–20. PFO is a remnant of fetal circulation

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PFO CLOSURE

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  1. PFO CLOSURE JOURNAL REVIEW OF EVIDENCE

  2. Hagen PT, Scholz DG, Edwards WD. Incidence and size of patent foramen ovale during the first 10 decades of life: an autopsy study of 965 normal hearts. Mayo Clin Proc. 1984;59:17–20. PFO is a remnant of fetal circulation At autopsy-Identified in 27% of normal patients Prevalence decline with age

  3. Di Tullio MR, Sacco RL, Sciacca RR, et al. Patent foramen ovale and the risk of ischemic stroke in a multiethnic population. J Am CollCardiol.2007;49:797– 802. Contrast TTE Detected PFO in 14.9% stroke-free subjects >39 yrs Atrial septal aneurysm 2.5% Most often in association with PFO

  4. Meissner I, Khandheria BK, Heit JA, et al. Patent foramen ovale:innocentor guilty? Evidence from a prospective population-based study.JAm CollCardiol. 2006;47:440 –5. TEE 24.3% prevalence rate in > 45 yrs age Atrial septal aneurysm 1.9% of subjects 4.3% associated with PFOs

  5. DIAGNOSIS TTE and TEE with saline contrast injection PFO is established by demonstration of an interatrial communication with right-to-left transit of contrast microbubbles within 3 to 4 cardiac cycles of right atrial opacification

  6. Injection is performed with and without Valsalva maneuver • Coughing during injection increase sensitivity • Use of harmonic imaging increase sensitivity • Contrast material injected into lower extremities has higher sensitivity

  7. Atrial septal aneurysm is defined as a redundant and hypermobile portion of the interatrial septum that demonstrates more than 10-mm excursion from centerline during cardiac cycle

  8. CRYPTOGENIC STROKE No identifiable cause despite thorough evaluation Approximately 25% to 40% Up to 25% of patients experience recurrent stroke or TIA within 4 years of initial event despite medical therapy

  9. PFO AND CS Association was first reported in 1988 by Lechat et al Numerous observational studies suggested a strong association More convincingly demonstrated for younger (< 55 yrs age) than older patients (>55 yrs )

  10. Relationship of Cryptogenic Stroke With PFO in Younger and Older Patients

  11. Lamyet al-PFO with TEE in 45.9% of 581 young CS patients

  12. Handke M, Harloff A, Olschewski M, et al. PFO and cryptogenic stroke in older patients. N Engl J Med. 2007;357:2262– 8. Prevalence of PFO 43.9% among younger CS patients compared with 14.3% among younger patients with stroke of known cause (odds ratio 4.70, 95% ,[CI] 1.89 to 11.68, P0.001) 28.3% among older CS patients compared with 11.9% among older patients with stroke of known cause (odds ratio 2.92, 95% CI 1.70 to 5.01, P0.001)

  13. PFO in Cryptogenic Stroke Study (PICSS) PFO by TEE criteria in 33.8% of patients 30 to 85 years PFO in 39.2% of CS patients versus 29.9% of patients with a known cause of stroke (P0.02). Homma S: Circulation, Volume 105(22).June 4, 2002.2625-2631

  14. Prospective population-based study by Meissner et al PFO was not found to be an independent risk factor for future cerebrovascular events in the general population after correction for age and comorbidity

  15. Northern Manhattan Study (NOMAS) PFO not associated with increased stroke risk in a multiethnic cohort of both men and women or in patients younger or older than 60 years

  16. Olmsted County SPARC study PFO is not a significant, independent predictor of stroke among normal subjects older than 45 yrsof age

  17. Factors Associated With ParadoxicalEmbolization Atrial Anatomy Anatomic size of PFO Magnitude of right-to-left shunt Coexistence of atrial septal aneurysm Eustachian Valve and Chiari’s Network Hemodynamics Venous Thrombosis and HypercoagulableStates These associations have not been observed consistently

  18. Estimates of annual rates of recurrent stroke among patients with PFO range from 1.5% to 12% and depend on the characteristics of the population , age Optimal medical therapy for prevention of recurrent CS is unknown Numerous uncontrolled studies have shown an apparent benefit of medical therapy after a CS

  19. Summary Table of Medical Therapy Studies

  20. Lausanne study Patients were treated with aspirin, anticoagulation or PFO closure-annual stroke rate was 1.9%

  21. WARSS Warfarin Aspirin Recurrent Stroke Study First randomized controlled study to compare the effect of warfarin and aspirin after prior noncardioembolic ischemic stroke Showed aspirin was as good as warfarin in prevention of stroke recurrence, but presence of PFO was not specifically systematically evaluated Majority of subgroup analyses in the WARSS showed no benefit of warfarin over aspirin.

  22. PICSS Patients older than those in the Lausanne study All subjects were treated with aspirin (325 mg daily) or warfarin(INR 1.4 to 2.8,mean 2.040.99). 2-year primary event rate for all-cause death or recurrent ischemic stroke was 15.9%. No significant difference in primary event rates between patients with versus those without PFO

  23. Percutaneous Closure of PFO • Transcatheter closure first reported in 1992 -Bridges, Lock, et al • Most commonly used devices are • AmplatzerPFO Occluder (AGAMedical) • CardioSEAL(NMT Medical) devices

  24. Summary Table of Percutaneous PFO Closure Studies

  25. Khairy P, O’Donnell CP, Landzberg MJ. Transcatheter closure versus medical therapy of PFO and presumed paradoxical thromboemboli: a systematic review. Ann Intern Med. 2003;139:753– 6 Systematic review of nonrandomized studies of transcatheterclosure (n10) or medical therapy (n6)

  26. Wöhrle J. Closure of patent foramen ovale after cryptogenic stroke.Lancet. 2006;368:350 –2. Wöhrle’s-recent review of nonrandomized trials Suggested lower rate of recurrent stroke after device closure of PFO, especially among patients with coexistent atrial septalaneurysm Mean frequency of major complications was 2.3% among patients undergoing PFO closure

  27. Kutty S, Brown K, Asnes JD, Rhodes JF, Latson LA. Causes of recurrent focal neurologic events after transcatheter closure of patent foramen ovale with the CardioSEAL septal occluder. Am J Cardiol 2008;101:1487–92. Kutty et al. Analyzed results of investigations performed for neurological events after PFO device closure and reported a combined recurrence rate of 3.4% for stroke/TIA and an event rate of 0.9% per year for recurrent strokes

  28. Summary Table of Surgical PFO Closure Studies

  29. AHA/ASA guidelines for secondary stroke prevention state that “insufficient data exist to make a recommendation about PFO closure in patients with a first stroke and a PFO” PFO closure may be considered for patients with recurrent CS despite optimal medical therapy (Class IIb, Level of Evidence: C)

  30. No device specific for PFO closure after CS has been approved by FDA Need for completion of appropriately powered randomized, controlled clinical trials to compare medical therapy with percutaneous device closure

  31. Current Ongoing Clinical Trials on PFO Closure to Prevent Recurrent Cryptogenic Stroke

  32. CLOSURE I TRIAL Evaluation of the STARFlexSeptal Closure System in Patients With a Stroke or TIA due to Presumed Paradoxical Embolism through a PFO Prospective, multi-center, randomized, open-label, two-arm superiority trial Patients < 60 years with CS or TIA and PFO documented by TEE, with or without atrial septal aneurysm, within 6 months of randomization

  33. STARFlex® Double umbrella comprised of MP35N framework with attached polyester fabric 23mm, 28mm, 33mm

  34. N = 909 N=447 N=462 Between June 23, 2003 and October 24, 2008, 909 patients were randomized at 87 sites in the United States and Canada.

  35. Primary endpoint : 2-year incidence of stroke or TIA, all cause mortality for the first 30 days, and neurological mortality 31 days to 2 years Followup Repeat TEE at 6 months all patients and 12/24 months if residual leak

  36. 2 Year Primary Endpoint ITT *Adjusting performed using Cox Proportional Hazard Regression and adjusting for related patient characteristics including: age, atrial septal aneurysm, prior TIA/CVA, smoking, hypertension, hypercholesterolemia

  37. Composite Primary EndpointBaseline Shunt and Atrial Septal Aneurysm (TEE)

  38. Adverse Events *Perforation LA (1); hematoma >5cm at access site (4); vascular surgical repair (1); peripheral nerve injury (1); procedural related transfusion (3);retroperitoneal bleed (3)

  39. CONCLUSIONS • First completed, prospective, randomized PFO device closure study • Superiority of PFO closure with STARFlex® plus medical therapy over medical therapy alone was not demonstrated • No significant benefit related to degree of initial shunt • No significant benefit with atrial septal aneurysm • Insignificant trend (1.8%) favoring device driven by TIA • 2 year stroke rate essentially identical in both arms (3%)

  40. Major vascular (procedural) complications in 3% of device arm Significantly higher rate of AF in device arm (5.7%) 60% AF periprocedural Alternative explanation unrelated to paradoxical embolism present in 80% of patients with recurrent stroke or TIA

  41. Percutaneous closure with STARFlex® plus medical therapy does not offer any significant benefit over medical therapy alone for the prevention of recurrent stroke or TIA in patients < age 60 presenting with cryptogenic stroke or TIA and a PFO

  42. Migraines Del Sette et al first reported association between migraine with aura and right-to left shunts detected with transcranial Doppler Presumed association of PFO with migraines relates to paradoxical embolism or humoral factors that escape degradation in bypassing the pulmonary circulation

  43. Wilmshurst PT, Nightingale S, Walsh KP, Morrison WL. Effect on migraine of closure of cardiac right-to-left shunts to prevent recurrence of decompression illness or stroke or for haemodynamicreasons.Lancet2000;356:1648 –51 A retrospective evaluation of effect of transcatheterclosure of atrial shunts on migraine symptoms suggested a causal association between right-to-left shunts and migraine with aura

  44. Azarbal B, Tobis J, Suh W, Chan V, Dao C, Gaster R. Association of interatrial shunts and migraine headaches: impact of transcatheter closure. J Am CollCardiol 2005;45:489 –92. Complete resolution of migraines in 60% of patients and improvement in symptoms in 40% of patients after transcatheter closure of atrial shunts

  45. Wahl et al. Evaluated migraine symptoms at a mean follow-up of 5years in a retrospective cohort of patients who had transcatheter PFO closure for secondary prevention of paradoxical embolism suggesting beneficial reduction of symptoms, especially in migraine with aura

  46. Garg P, Servoss SJ, Wu JC, et al. Lack of association between migraine headache and patent foramen ovale: results of a case-control study. Circulation 2010;121:1406 –12. GargP etal Recent large case-control study No association was found between migraines and presence of PFO

  47. MIST 147 patients with a history of severe migraines and without any other indication for PFO device closure were randomized to undergo either device closure or a sham procedure Patients were treated with aspirin and clopidogrel No significant difference in the primary outcome of headache cessation was detected between the 2 groups 3 to 6 months after the procedure On exploratory analysis, excluding 2 outliers, the closure group showed a greater reduction in migraine headache days compared with the sham group

  48. Current Ongoing Clinical Trials on PFO Closure to PreventMigraine PRIMA (PFO Repair in Migraine With Aura) PREMIUM (Prospective Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using Amplatzer PFO Occluder Compared to Medical Management)

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