1. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Presenter disclosure information name: Frank Uhlemann In the last 12 month the presenter had contact to the following companies. There is no conflict of interests companycontact AbbottconsultantF.Uhlemann St. Jude medicalconsultantF.Uhlemann

2. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Interventional PFO-Closure Using The Premere Device A Single-Center Experience F. Uhlemann Center for Congenital Heart Disease Stuttgart Olgahospital Advanced Angioplasty 2007 London 26th January

3. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Device design Tether Lock Delivery System Release Mechanism Left Atrial Anchor Right Atrial Anchor

4. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Device - Optimal anatomic adaptation long Track Keypoints: flexible length of connection between both anchors low content of metal slim design especially on left side Separate steerability of left and right atrial anchor Sizes: (15mm), 20mm and 25mm diameter short Track

5. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T 30 day porcine implant left atrial anchor right atrial anchor Device - rapid and complete endothelialisation

6. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Procedure - the way we do it in Stuttgart Pre intervention complete neurologic workup workup for coagulation disorders, e.g. thrombophilia TOE with bubble study and Valsalva During intervention sedation on demand full heparinisation (100 IU/kg, single dose) short term antibiotic prophylaxis Post intervention heparinisation for 24 hours Drugs: commencing 12h post implantation aspirin (low dose) and clopidogrel for 3months aspirin (low dose)for next 3 months Follow up examinations (ecg, echo, holter-ecg, clinical): 3-4 weeks (TOE for thrombus formation) 6 months (TOE for complete closure) 1 year

7. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Procedure - balloonsizing„sense or nonsense“ low pressure balloon, TOE, echo contrast and abdominal pressure pro: to get an idea of the track morphology, diameter, stiffness, length to exclude additional defects con:expensive, need for longer TOE What you can miss without echo guidance: Chiari network large Eustachian valve overriding of SVC partial anomalous pulmonary venous drainage subdivided left atrium We perform balloon sizing in every patient We recommend echo guidance in every patient

8. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T The way we do it – intervention/balloonsizing long track versus short track waist at different levels same level

9. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Deployment of device - steps deployment of left atrial anchor „free floating“ in left atrium self orientation towards the septum deployment of right atrial „patched“ anchor individual steerability and option for repositioning

10. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Deployment of device - steps locking of both parts and opening of snare true image of the final position before final release final release cutting the tether, superior conformability

11. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Interventional closure of pFO – patients -device selection n = 69 Implantation periods period 1: from 10/2004 to 05/2005 only 20mm Premere device available period 2: from 06/2005 to 08/2006 20mm and 25mm device available device selection according to patients anatomy patients 99 patients with intention for closure - 99 patients successful closure procedure 69 patients suitable for Premere device and enrolled Age (years): mean +/-SD46,10 +/- 11,05 Range(20 – 75) Male sex % (n)49,3 (34) History of cryptogenic ischaemic stroke % (n)41,8 (29) transient ischaemic attack % (n)58,2 (40) Follow up mean follow up11,1 months

12. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Results - closure rate ? to our understanding at early stage irrelevant

13. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Results - complications 69 patients with Premere device major complications: device embolisation1** need for surgerynone thrombus formation left sidenone cerebral events1 TIA* * despite successful closure ** without clinical symptoms minor complications: bleeding (need for transfusion)none thrombus formation right sidenone rhytm disturbances permanentnone rhytm disturbances intercurrent1 need for drug1

14. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Current limitations for 25mm Premere device pFO morphology wide opening of right or left side of the track (entrapment of the anchor) >15mm very large aneurysm left right shunting (debatable) multiperforated pFO

15. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Summary- interventional closure of pFO Premere device (St. Jude Medical) good closure rate suitable for about 70% of our unselected patient group easy implantation procedure excellent adaptation to individual anatomy rapid endothelialisation low complication rate

16. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Thank you

17. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T Possible indications for interventional closure of pFO Neurologic indication (prevention of paradoxical embolism) patients with stroke, PRIND, TIA or other embolic history assumed to be paradoxic patients with severe migraine special patient groups: professional scuba divers (prevention of decompression disease) jet pilots women with evidence of hypercoagulation and wish for pregnancy Hemodynamic indication (prevention of right-left-shunting) RV-failure due to RV-infarction cyanotic patients with COLD

18. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T interventional closure of pFO follow up, detection of residual shunts TOE sometimes low intensity of valsalva noninvasive- accuracy depends on site of intravenous injection ICE invasive, expensive TCD sometimes low intensity of valsalva noninvasive accuracy depends on site of intravenous injection

19. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T interventional closure of pFO

20. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T interventional closure of pFO

21. C E N T E R F O R C O N G E N I T A L H E A R T D I S E A S E S T U T T G A R T interventional closure of pFO