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Disclosure Information. Devices for ASD&PFO Closure: Amplatzer Devices. Alpay Celiker M.D. As a faculty member for this program, I disclose the following relationships with industry: No Conflict Of Interest. ASD/PFO Closure Amplatzer Devices. Alpay Celiker M.D.

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  1. Disclosure Information Devices for ASD&PFO Closure: Amplatzer Devices Alpay Celiker M.D. As a faculty member for this program, I disclose the following relationships with industry:No Conflict Of Interest

  2. ASD/PFO ClosureAmplatzer Devices Alpay Celiker M.D. Acibadem University, Department of Pediatric Cardiology Istanbul, Turkey.

  3. Amplatzer Devices Used for ASD/PFO Closures • Amplatzer Septal Occluder • Cribriform Occluder • Amplatzer PFO Occluder

  4. Amplatzer Septal Occluder (ASO) • Self-expandable double disk device made of nitinol • Constructed from nitinol wire mesh • It consists two disks connected with waist which relates device size. • Polyester fabric is sewn to two disks and waist to increase the occlusion • Approved by FDA in 2001

  5. Amplatzer Septal Occluder • Device Size: 4-40 mm • 4-20 mm: 1 mm increase • 20-40 mm : 2 mm increase • Connecting waist width: • 4-10 mm: 3 mm • >10 mm : 4 mm • LA disk size • 4-10 mm : 12 mm larger • 11-34 mm: 14 mm larger • >34 mm : 16 mm larger • Delivery sheath: 6-14 F, 45o angled tip, 60-80 cm lenght

  6. Procedure • Echocardiography: TE, TT and IC Echo guidance • Balloon Sizing • Stop-flow • No balloon sizing • Device Selection: • Balloon sizing: 0-2 mm larger; if aortic rim deficient 4 mm larger • Without Balloon Sizing: • Adults: 4-6 mm larger • Children. 2-4 mm larger

  7. ASO: Results (FDA DATA) • Procedure success rate 97,6 % • Complete closure rate: • 1 day: 96,7 %, 6 months: 97,2 %, 1 year: 98,5 % • Major adverse events: 7 (1,6 %) • Device embolization: 4, Cardiac arrhythmia: 2, Delivery system failure: 1 • Minor adverse events: 27 (6,1 %) • Cardiac arrhythmia: 15, Thrombus formation: 3, Headache, allergic reaction and delivery system failure: 6

  8. ASO: Complications • Device Embolization/Migration: % 1 • Arrhythmia: Supraventricular arrhythmias are more common at immediate period. • Cardiac Erosion and Perforation: Reported as 0,1 % of patients. Cardiac perforations involve the anterio-superior atrial wall or adjacent aorta.It may be seen in patients with deficient aortic and posterior rim with use of oversized defect. High-risk patients should be followed by serial echo exams in patients with increasing or new pericardial effusion at the next day echo. • Thrombus Formation • Cobra-head Formation

  9. Closure of ASDwith the ASO in Children Everett et al. Ped Cardiol, 2008: MAGIC study

  10. Closure of ASDwith the ASO in Adults Majunke et al. Am J Cardiol. 650 patients with a 97% success rate

  11. Cribriform Occluder • Designed to closure multifenestrated defect • Both disk diameters are equal and connecting waist is short. • Disk sizes • 18 mm ,25 mm, 30 mm, 35 mm, 40 mm (not available in US)

  12. ASD Closure: Multifenestre Defects • Cath Cardiovasc Interv 61:2004. •  J Invas Cardiol 17: 2005 •  Ped Card 2007.

  13. Amplatzer PFO Occluders Three sizes 18 mm : Both disks are 18 mm 25 mm: Right disc 25 mm, left disc 18 mm 35 mm: Right disc 35 mm, left disc 28 mm

  14. Closure of PFO with the Amplatzer Septal Occluder Taaffe et al. Am J Cardiol, 101;2008.

  15. Thank you

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