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

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

Amplatzer Devices Used for ASD/PFO Closures Amplatzer Septal Occluder Cribriform Occluder Amplatzer PFO Occluder

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

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, 45 o angled tip, cm lenght

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

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

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

Closure of ASD with the ASO in Children ASD TypeTotal 478Simple % Complex % ImagingTEE 70%ICE 19 %TTE 9% Device Number1 device 93%>1 device 7% SuccessTotal 96%Simple 94,9 %Complex 98,4% ComplicationsThrombus 1 patient 0,2 % Vessel problem 1 patient 0,2 % Minor Complications 22 patients 4,8 % Device Embolization Embolization surgical removal 3 patients 0,7 % Embolization percutaneous removal 5 patients 1,1% Everett et al. Ped Cardiol, 2008: MAGIC study

Closure of ASD with the ASO in Adults ComplicationsProcedural<30 DAYS>30 DAYS Embolization2 (0,3%)4 (0,6%)- Atrial Fib.-17 (2,6%)11 (1,7%) Hemopericardium-2 (0,3%)- Pericardial tamponade --1 (0,2%) Thrombus formation --1 (0,2%) TIA-1 (0,2%)2 (0,3%) Pericardial Effusion 5 (0,8%)2 (0,3%) Majunke et al. Am J Cardiol. 650 patients with a 97% success rate

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)

ASD Closure: Multifenestre Defects Szkutnik et al  Zanchetta et al  Numan et al  Device typeASOKribriform Number Success Closure Rate 1 day 61%77% Closure rate 1 year 8692%  Cath Cardiovasc Interv 61:2004.  J Invas Cardiol 17: 2005  Ped Card 2007.

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

Closure of PFO with the Amplatzer Septal Occluder Procedure DetailsProcedure time 28,6 min Floroscopy time 4,1 min Hospital stay 18,6 hours Device type 184 patient ;25 mm ComplicationsTamponade 1 patient Atrial fibrillation 3 patients Follow-upClosure or Minimal Shunt: 94% Taaffe et al. Am J Cardiol, 101;2008.