PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE AND ATRIAL SEPTAL DEFECT: STATE OF THE ART AND A CRITICAL APPRAISAL

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1 PERCUTANEOUS CLOSURE OF PATENT FORAMEN OVALE AND ATRIAL SEPTAL DEFECT: STATE OF THE ART AND A CRITICAL APPRAISAL Carmelo Cernigliaro Clinica San Gaudenzio Novara

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4 Eco 2D e 3D

5 Eco Transesofageo

6 Large shunt with transcranial Doppler Souteyrand, G. et al. Eur J Echocardiogr : ; doi: /j.euje

7 Impianto di INTRASEPT

8 PFO: Clinical Presentation Migraine with or without aura STROKE or TIA Decompression sickness Plathypnea-orthodeoxia syndrome

9 Cephalalgia May;28(5): Epub 2008 Mar 17. Patent foramen ovale and migraine: a quantitative systematic review. Schwedt TJ, Demaerschalk BM, Dodick DW. A quantitative systematic review of 18 articles. The estimated strength of association between PFO and migraine, reflected by summary odds ratios (ORs), was 5.13 [95% confidence interval (CI) 4.67, 5.59], and between PFO and migraine with aura the OR was 3.21 (95% CI 2.38, 4.17). The association between migraine and PFO was OR 2.54 (95% CI 2.01, 3.08).

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13 Stroke recurrence in patients with patent foramen ovale: the Lausanne Study. Lausanne Stroke with Paradoxal Embolism Study Group. Bogousslavsky J, Garazi S et al. Neurology. 1996;46: Patent foramen ovale (PFO) is more common in patients with stroke than in matched controls. We studied recurrences of stroke in 140 consecutive patients (mean age 44 +/- 14 years) with stroke and PFO admitted to a population-based primary-care center. During a mean follow-up of 3 years, the stroke or death rate was 2.4% per year, but only eight patients had a recurrent infarct (1.9% per year). This low rate of recurrence contrasted with the severity of initial stroke. Multivariate analysis showed that interatrial communication, a history of recent migraine, posterior cerebral artery territory infarct, and a coexisting cause of stroke were associated with recurrence In conclusion, our study shows that stroke associated with PFO is usually embolic, although a definite source cannot often be demonstrated.

14 Probability That Patients Will Remain Free from Recurrent Stroke or Transient Ischemic Attack (TIA), According to the Presence or Absence of Atrial Septal Abnormalities. Mas J et al. N Engl J Med 2001;345:

15 Kohei Hayashida, Journal of Nuclear Medicine 2001; 42 (6)

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21 ESC Stockholm 2010 Residual shunt after percutaneous closure of a patent foramen ovale. Results of a 3-year follow-up study. Objectives: To assess residual shunt, adverse events, migraine disability, up to 7 years after a patent foramen ovale (PFO) closure.

22 Methods Between 2002 and 2009, 87 consecutive patients underwent bubble contrast echocardiography re-study to assess residual right-to-left shunt, 1 year after closure with a CARDIA PFO device. Transcranial doppler was performed at 6 months and at 1 year. Office visits or telephone contacts were obtained every 6 months during an observation period of 3.3±1.7 years (range, years).

23 Study population (87 patients) Age, y 48.2±14.7 History of ischemia: Sex Male 35.6% - stroke 55.2% Hypertension 37.9% - TIA 41.4% Dyslipidemia Coagulation defect Atrial septal aneurism 31.0% 3.4% 41.4% - IHD 3.4%

24 Migraine headache presentation 70% 60.9% 60% 50% 40% 21.8% 30% 17.3% 20% 10% 0% Migraine with Aura Migraine without aura Non migraineurs

25 Vascular stroke territory at MRI 70% 50.0% 60% 39.6% 50% 40% 30% 20% 10.4% 10% 0% Anterior Posterior Border zone

26 CARDIA DEVICE

27 Results Incidence of residual shunt at 1 year 33.3% effective closure residual shunt 66.7%

28 Results

29 Results Migraine resolution or relief vs residual shunt 80% 71.3% p= % 60% 46.6% no shunt 50% 40% p= % residual shunt 30% 20% 17.2% 10% 0% Resolution Relief

30 Adverse events Adverse events during the 3-year follow-up were: 5 TIAs and 1 surgical PFO closure redo for intractable migraine.

31 Results Aura and residual shunt were significantly associated with adverse events ADVERSE EVENTS: 40% 36.4% p=0.002 presence absence 35% 30% 25% 21.7% p= % 15% 10% 5% 3.3% 2.2% 0% Aura Residual shunt

32 CARDIA COMPLICATIONS: 4 out of 87 pts (4.6%) Oesophagus perforation: 1 Left auricola perforation and tamponade: 1 Inferior NSTEMI: 1 Femoral vein A-V Fistula: 1

33 Conclusions Residual shunt after PFO closure is associated with adverse events and persistent migraine disability.

34 Who should undergo PFO closure? Cryptogenic stroke with large PFO and ASA and spontaneous right to left shunt Cryptogenic stroke which recurs despite anticoagulant therapy Cryptogenic stroke which recurs and patient would not comply long term anticoagulation

35 Percutaneous device closure of patent foramen ovale for secondary stroke prevention. A CALL FOR COMPLETION OF RANDOMIZED CLINICAL TRIALS A science advisory from the American Heart Association/ American Stroke Association and the American College of Cardiology Foundation. The American Academy of Neurology affirms the value of this science advisory. O Gara et al. J Am Coll Cardiol 2009;53:

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47 PERCUTANEOUS ASD CLOSURE NO ONE IS TOO OLD TO BE CLOSED

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51 Territori cerebrali vascolari

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