1. J.V. DeGiovanni Birmingham Children’s Hospital & University Hospital Birmingham UK Advanced Angioplasty 2007 Ventricular Septal Defects Transcatheter Closure

2. MY CONFLICTS OF INTEREST ARE: Consultant for AGA Medical Corporation Proctor and lecturer for AGA Medical, NMT Medical, WL Gore Steering Committee member for Helex (Gore), SolySafe (Carag), BioStar (NMT)

3. Study Details September 2001 – January 2007 September 2001 – January 2007 Total number VSD devices : 160 Total number VSD devices : 160 Muscular Devices: 59 Muscular Devices: 59 Perimembranous Devices: 43 Perimembranous Devices: 43 Post-infarct: 43 Post-infarct: 43 Post-trauma: 3 Post-trauma: 3 Residual post-surgery 12 Residual post-surgery 12

4. VSD Types Congenital:Perimembranous, Muscular, Gerbode, Doubly-committed Congenital:Perimembranous, Muscular, Gerbode, Doubly-committed Acquired:Iatrogenic Acquired:Iatrogenic Residual post-surgery Post-traumaPost-infarct

5. Indications Left ventricular volume overload Left ventricular volume overload Heart failure/Cardiogenic shock Heart failure/Cardiogenic shock Aortic regurgitation Aortic regurgitation Haemolysis Haemolysis History of endocarditis History of endocarditis Career reasons Career reasons Achieving normality (?) Achieving normality (?)

6. Technique General Anaesthesia General Anaesthesia Trans-oesophageal echocardiography Trans-oesophageal echocardiography Femoral vein/femoral artery Femoral vein/femoral artery Internal jugular vein/femoral artery Internal jugular vein/femoral artery Angiography Angiography +/- Balloon sizing (post-MI only) +/- Balloon sizing (post-MI only) Amplatzer device placement and release Amplatzer device placement and release Heparin, antibiotics, antiplatelets Heparin, antibiotics, antiplatelets Associated procedures (ASD, BAV, RFA, VSD coil, Pulm Valvuloplasty) Associated procedures (ASD, BAV, RFA, VSD coil, Pulm Valvuloplasty)

20. Amplatzer Muscular Devices MuscularWaist diameter 4 – 18 mm MuscularWaist diameter 4 – 18 mm Waist length 7 mm Sheath size 6 – 8 Fr Muscular PIWaist diameter 16 -24 Muscular PIWaist diameter 16 -24 Waist length 10 mm Sheath size 9 – 10 Fr Left disc rim 4 mm, right disc 3mm, size increments 2 mm

21. Muscular VSDs Inlet Inlet Muscular/Apical Muscular/Apical Outlet Outlet

22. Muscular Inlet

25. Mid-Muscular

29. Muscular Outlet

30. Multiple VSDs

31. Horse Kick, surgery, 3 devices, alive Horse Kick, surgery, 3 devices, alive Bike accident, device closure, alive Bike accident, device closure, alive Car accident, device pulled through, surgery, died Car accident, device pulled through, surgery, died Post-trauma n = 3

34. Pt No = 38; Procedures = 43 Pt No = 38; Procedures = 43 Male/Female = 22/16 Male/Female = 22/16 Age Range(Mean) = 52 – 81 (68.6 yrs) Age Range(Mean) = 52 – 81 (68.6 yrs) Acute/Chronic (First device) = 29/9 Acute/Chronic (First device) = 29/9 Acute/Chronic (Second device) = 3/2 Acute/Chronic (Second device) = 3/2 Mean Interval between MI and Closure 129 days Mean Interval between MI and Closure 129 days Ditto for second device 201 days Ditto for second device 201 days Earliest device 2 days, longest 5.3 yrs Earliest device 2 days, longest 5.3 yrs Mean Follow-up 18.8 months Mean Follow-up 18.8 months Post-infarct VSD Patient Details -- ALL

35. Apical18 Apical18 Anterior6 Anterior6 Muscular5 Muscular5 Inlet/Inferior9 Inlet/Inferior9 Septal aneurysm6 Septal aneurysm6 Multiple5 Multiple5 No of defects (No of Pts) 2(2), 3(1), 4(1) VSD Site

36. FA/Jugular30 FA/Jugular30 FA/FV 12 FA/FV 12 Brachial A/Jugular 1 Brachial A/Jugular 1 Procedure Time55 – 300 (153) Mins Procedure Time55 – 300 (153) Mins Fluoro Time13.6 – 133 (39) Mins Fluoro Time13.6 – 133 (39) Mins Device size8 – 24 (18.7) Device size8 – 24 (18.7) Approach

37. Planning & Preparation Maximize fluids and inotropes Maximize fluids and inotropes IABP but shoot coronaries and consider vital stenting IABP but shoot coronaries and consider vital stenting Allow recovery from reperfusion injury Allow recovery from reperfusion injury Early intervention is usually best Early intervention is usually best Minimize procedural time and trauma Minimize procedural time and trauma Surgical back-up Surgical back-up Post-Op care Post-Op care Possible hybrid in some cases Possible hybrid in some cases

41. Aortic Pressure Black = Baseline Red = With Balloon

48. Courtesy Dr John Davis

50. Courtesy Dr Huon Gray

53. Major complications Leg gangrene1 Leg gangrene1 Contra leg embolus1 Contra leg embolus1 IABP sepsis1 IABP sepsis1 Inadequate post-op care1 Inadequate post-op care1 Device embolisation2 Device embolisation2 TV damage (repaired)1 TV damage (repaired)1 No endothelialisation (surgery)1 No endothelialisation (surgery)1 Pericardial effusion2 Pericardial effusion2 Failure (VSD too large)2 Failure (VSD too large)2 Death 12 Death 12 (All=31.5%, Cardiac 26.3%, Ideal 15.7%) (All=31.5%, Cardiac 26.3%, Ideal 15.7%)

54. Conclusion Transcatheter closure of VSDs in various locations can be safely and effectively carried out using the Amplatzer occluders Transcatheter closure of VSDs in various locations can be safely and effectively carried out using the Amplatzer occluders Results are encouraging. Muscular defects comparable to surgery; perimembranous marginally less good than surgery. Post-infarct still carry high risk but better results than surgery Results are encouraging. Muscular defects comparable to surgery; perimembranous marginally less good than surgery. Post-infarct still carry high risk but better results than surgery Long term follow-up essential Long term follow-up essential Design changes likely to follow Design changes likely to follow Acknowledgment Acknowledgment

55. Acknowledgement Been M, Clift P,Davis J, Flapan D, Gray H, Hildick Smith D, Jenkins J, Khogali S, Ludman P, Northridge D, Thorne S, Townend J, Turner M, Walker M,Wheeldon N Been M, Clift P,Davis J, Flapan D, Gray H, Hildick Smith D, Jenkins J, Khogali S, Ludman P, Northridge D, Thorne S, Townend J, Turner M, Walker M,Wheeldon N

66. Perimembranous n = 42 Simple Simple With aneurysm:Single exit With aneurysm:Single exit Multiple exits Windsock in RVOT Aortic valve prolapse Aortic valve prolapse

71. Muscular Device n = 70 Congenital Muscular VSD22 Congenital Muscular VSD22 Congenital Perimembranous VSD36 Congenital Perimembranous VSD36 Post-surgery residual 9 Post-surgery residual 9 Post-trauma 3 Post-trauma 3 Associated procedures: P. Valvuloplasty(1), PA band dilatation (1) Associated procedures: P. Valvuloplasty(1), PA band dilatation (1)

74. TGA, Switch, Absent IVC, VSD

80. Muscular Outlet

83. Ebstein LV to RA

87. Perimemb/Musc Devices Failed in 4:VSD too large (Post-trauma) Failed in 4:VSD too large (Post-trauma) Device caused LVOTO Post-Fallot 3 rd Op. VSD too big Transient AV block with sheath No conduction problems apart from 3 with LAHB, normal PR No conduction problems apart from 3 with LAHB, normal PR No TR, AI, clots, infection No TR, AI, clots, infection Device embolisation in 2 with PMVSD.Retrieved & replaced Device embolisation in 2 with PMVSD.Retrieved & replaced Device removed severe haemolysis + large shunt Device removed severe haemolysis + large shunt Transient mild haemolysis in 2 (Resolved) Transient mild haemolysis in 2 (Resolved) No deaths No deaths Small residual shunt in 6 Small residual shunt in 6

92. Off Label Usage of Amplatzer Muscular Occluder Membranous VSD with aneurysm Membranous VSD with aneurysm Huge PDAs Huge PDAs Large AV malformations Large AV malformations Paravalvar prosthetic leaks Paravalvar prosthetic leaks

96. Iatrogenic

98. Residual Post-Op