Disclosure%20Information

1
Disclosure Information
Devices for ASDPFO Closure Amplatzer Devices
Alpay Celiker M.D.
As a faculty member for this program, I disclose
the following relationships with industryNo
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
• gt10 mm 4 mm
• LA disk size
• 4-10 mm 12 mm larger
• 11-34 mm 14 mm larger
• gt34 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 ASD with the ASO in Children
ASD Type Total 478 Simple 355 76 Complex 123 24
Imaging TEE 70 ICE 19 TTE 9
Device Number 1 device 93 gt1 device 7
Success Total 96 Simple 94,9 Complex 98,4
Complications Thrombus 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
10
Closure of ASD with the ASO in Adults
Complications Procedural lt30 DAYS gt30 DAYS
Embolization 2 (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
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
Szkutnik et al? Zanchetta et al?? Numan et al???
Device type ASO Kribriform Kribriform
Number 41 24 16
Success 39 24 13
Closure Rate 1 day 61 77 77
Closure rate 1 year 86 92 92

• Cath Cardiovasc Interv 612004.
• ? 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
Procedure Details Procedure time 28,6 min Floroscopy time 4,1 min
Hospital stay 18,6 hours Device type 184 patient 25 mm
Complications Tamponade 1 patient Atrial fibrillation 3 patients
Follow-up Closure or Minimal Shunt 94
Taaffe et al. Am J Cardiol, 1012008.
15
Thank you