1. New AGA Devices PDA II, Vascular Plug IV, Membranous VSD and and Left Atrial Appendage Occluder Dr. John M. Lasala MD PhD Director Interventional Cardiology and Cardiac Cath Barnes-Jewish Hospital Professor of Medicine Washington University St. Louis, Missouri

2. Conflict of Interest Speaker and Proctor AGA Medical/ St Jude Medical Note: Some Products in this presentation are not FDA Approved

3. Patient complained of chest pain and dyspnea
LAD to RV Fistula
Patient complained of chest pain and dyspnea
CT Scan noted Fistula

4. LAO Cranial Projection Note enlarged hypocontractile RV

5. Forming the AV Loop
Choice Floppy Wire through Cook Miraflex Catheter placed in PA and captured with 25 mm Gooseneck Snare and externalized through right IJ

6. Positionment of Delivery Catheter
“Cut Down” 100 cm JR4 Catheter or 55cm Renal Catheter advanced over AV loop into LAD

7. Deployment of 8mm Amplatzer Vascular Plug II
Measurements are often Estimates!

8. Redeployment Using10 mm Vascular Plug II .
Note all three discs are exposed

9. Final Position of Vascular Plug
Note slow flow in LAD Without Shunt
Will need to keep on ASA and Coumadin
Revaluate in 6 months with CT Scan for Regression

10. Devices for Peripheral Vascular Occlusion AMPLATZER® Vascular Plug 4

11. Devices for Peripheral Vascular Occlusion
AMPLATZER®
Vascular Plug 4
AGA Medical Corporation
Device description
Dual-lobe, dual-layer Nitinol mesh with a floppy delivery wire tip for targeted delivery in distal and tortuous anatomy
Delivery system
0.035 Diagnostic Cath 4Fr
Device size
5 sizes from 4mm to 8mm
Product Approval and Indication
CE Mark Jul 2009 – Peripheral Vascular Occlusion

12. Gastroduodenal Artery Embolization with AVP 4 before Selective Internal Radiation Therapy
Courtesy Thomas Kroencke (DE)

13. PDA
Very common defect. True incidence unknown since many PDAs are silent
Indications for closure include evidence of LV or LA enlargement or the presence of a heart murmur consistent with the PDA
Treatment of “silent” PDAs controversial

14. PDA < approx 2 mm diameter may be closed with coil occlusion

15. Amplatzer duct occluder used for PDAs > 2 mm diameter
PDA device occlusion
Amplatzer duct occluder used for PDAs > 2 mm diameter

16. Amplatzer duct occluder First generation device must be delivered from pulmonary side

17. Amplatzer duct occluder

18. Devices for Closure of Structural Heart Defects
AMPLATZER® Duct Occluder II

19. AMPLATZER® Duct Occluder II
AGA Medical Corporation
Device description
Low-profile, self-expanding double braided nitinol device with two retention discs, central lobe. The symmetric design allows delivery from either arterial or venous approach.
Delivery system
4Fr or 5 Fr TorqVue Low Profile Catheter
Device size
8 sizes – 3, 4, 5, 6 mm waist each in 4 and 6 mm length
Product Approval and Indication
CE Mark Jan 2008 for PDA
U.S. Trial Jan 2008 for PDA

20. Devices for Closure of Structural Heart Defects
AMPLATZER® Duct Occluder II
Additional Sizes

21. AMPLATZER® Duct Occluder II
Additional Sizes
AGA Medical Corporation
Device description
Low-profile, self-expanding single-layer braided Nitinol device with two flat retention discs, central lobe, and micro end-screw designed to for less protrusion into the Aorta or Pulmonary Artery
Delivery system
4Fr TorqVue Low Profile Catheter
Device size
9 sizes – 3, 4, 5 mm waist each in 2, 4, 6 mm length
Product Approval and Indication
CE Mark Jan 2011 – Patent Ductus Arteriosus

22. ADO II AS Implantation

23. Congenital VSDs
VSDs are the most common form of congenital heart disease
Approx 20% of pts with CHD have a VSD as the solitary lesion
Echo studies demonstrate an incidence of 5-50/1000 newborns
Adult cardiologists mostly deal with post-MI VSDs

24. Congenital VSDs
Ventricular septum viewed from the RV is divided into the inlet (I), outlet (O), and trabecular portions (T)
Anatomic locations of VSDs include outlet (a), membranous (c), muscular(d,e,g), and inlet (f)

25. Congenital VSDs
Inlet and outlet type VSDs are not currently amenable to transcatheter closure
Muscular defects can be closed with either the Amplatzer muscular VSD occluder or the cardioseal device
Membranous VSDs can be closed with the Amplatzer membranous VSD device but this is not currently approved in the US

26. VSD Types 1 – outflow portion of RV
spontaneous closure uncommon
2 – perimembranous - most common – 80%
3 – inlet VSD in lower RV near TV, often in Down syndrome
4 – muscular, 20% of VSDs in infants, spontaneous closure is common
Warnes CA, et. al. VSD. ACC/AHA 2008 guidelines for the management of adults with congenital
heart disease. J Am Coll Cardiol 2008;52(23):e

27. Amplatzer Muscular VSD Device
6-8 Fr delivery sheath for MVSD
9-10 Fr delivery sheath for PIVSD

28. Amplatzer MVSD Implantation
LV angiogram
Selection of appropriate sized device based on TTE, TEE, & angiograms
Crossing of VSD and externalization of wire

29. Amplatzer MVSD Implantation
Removal of wire
Passage of device from transjugular of femoral venous approach

30. Amplatzer MVSD Implantation
Release of device from delivery system
Follow up angiogram

31. Devices for Closure of Structural Heart Defects
AMPLATZER® Membranous VSD 2

32. AMPLATZER® Membranous VSD 2
AGA Medical Corporation
Device description
Dual-layer braided Nitinol device with central waist, LV sail/wing-shaped disc, & RV circular disc designed to provided minimal force on the adjacent tissues while maintaining stability & closure
Delivery system
TorqVue 4 Delivery System (6-9 Fr) Pusher (6/7 & 8/9 Fr)
Device size
18 sizes
9 waist diameters: 4-10,12,14mm
Each available in rim lengths: 1mm & 3mm
Product Approval and Indication
CE Mark Anticipated Q – Membranous VSD

33. Implantation Video

34. Left Atrial Appendage Closure

35. Ubiquitous anatomy

36. Watchman Endocardial fourth generation

37. Coherex

38. AMPLATZER Cardiac Plug
(polyester material and thread not visible)
PROXIMAL
Disc
Proximal Screw attachment
Marker band
Central waist
Lobe
Platinum thread
Distal Screw attachment
Marker band
Stabilizing wire
DISTAL

39. AMPLATZER® Cardiac Plug
CE Mark 2008
Implants ongoing WW
EU Registry
First Patient Enrolled 8/2009
20 Sites
Sample size of >200
US IDE
Feasibility study initiated in Q3/2010
After completion of feasibility Pivotal phase of trial to begin

40. Thrombus in the LAA

41. AMPLATZER® Cardiac Plug

42. AMPLATZER® Cardiac Plug
Device Description
Transcatheter self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage
Delivery System
TorqVue® 45° x 45° Delivery Sheath: 9, 10 and 13 Fr. Sizes
Device Size
Eight sizes: 16 – 30 mm in 2 mm increment;
Disc Dia. 4 or 6 mm > Lobe Dia.;
Covering 18 – 28 mm LAA Orifice
Product Approval and Indication
CE Mark since Q4 2008
U.S. Clinical Feasibility Trial Q2 2010

43. ACP Implantation -Fluoroscopy

44. ACP Implantation - TEE

45. Conclusions 1. The newest Line of AGA products include upgrades of the vascular plug and ductal occluder and the introduction of the membranous VSD and cardiac LAA plug 2. None of these products are currently avavilable in the US but have ongoing European experience. 3. For now US physicians will have to make do with earlier generations The Cardiac LAA occluder hopes to begin randomized evaluation next year