1. Jonas D. Del Rosario, MD, FPCC Clinical Associate Professor UP College of Medicine

2. No disclosures

3. First DO NO HARM

4. Objectives  What types of VSD are amenable for catheter closure at this time  How to select and screen patients who are amenable for catheter closure of VSD  Concerns/Complications  Present our limited experience with the use of VSD coil in the Philippines

5. Ventricular Septal Defect  Most common congenital cardiac malformation  Surgery is the standard method for closure of VSD  Mortality rate in high volume centers is less than 0.6% to 1.8%  Complication < 1%  Complete heart block is less than 1%

6. VSD Closure with PFM VSD Coils

8. Transcatheter closure of VSD (TCCVSD)  Remains to be the most challenging interventional procedure in CHD  Various devices have been used with a high degree of effectiveness to primarily close muscular and perimembranous VSD

9. Advantages of TCC of VSD  Avoids median sternotomy scar  Avoids cardiopulmonary bypass  Shorter hospital stay  Shorter recovery period

10. Indication for Closure of VSD  Hemodynamically significant Qp:Qs > 1.5  LA or LV enlargement  Cardiomegaly on CXR  Failure to Thrive  Previous episode of Infective Endocarditis

11. Soft Indications for VSD Developed since catheter closure  Better psychosocial impact on patient  Avoid the inherent problems related to stigma of having a heart defect  Employability  Health Insurance  Heavy vehicle license  Sports participation (as a professional)

12. Concerns/Complications  Complexity of procedure  Steep Learning Curve  Applicability in selected group  Proximity of aortic and tricuspid valve  Conduction system (arrhythmias, heart block)  Residual shunt with risk of infective endocarditis  Mechanical haemolysis  Embolization

13. Proper selection of patients is the KEY.

14. What Is Amenable for TCC  Midmuscular or Apical Muscular VSD  Easier to close  Very few cases  Perimembranous ventricular septal defect

15. What Is Not Amenable For TCC  AV Canal Type (Inlet)  Large Perimembranous VSD(Unrestrictive)  Subpulmonic VSD  Multiple (Swiss Cheese) VSDs  VSD as a component of a more complex lesion

16. Amplatzer Muscular VSD occluder

17. Muscular VSD Device

18. Anterior Muscular VSD device

19. Amplatzer PM VSD Occluder (AVSO)  First device specifically designed for membranous VSD  First reported by Hijazi et al 2002 and Thanopoulos in 2003

20. Perimembranous VSD device

21. Amplatzer PM VSD occluder (AVSO)  Became the most popular device to close VSDs worldwide with good short and medium term outcome  Occurrence of complete heart block in an unpredictable manner even after years post- implantation has currently tempered the enthusiasm of the interventional community (Incidence 1-5%)

22. Heart Block of AVSO  Rim of the VSD closed by AVSO remains under continuous pressure due to the stenting philosophy of this device  This can cause trauma to the neighboring conduction system

23. What Type of Can Be Safely Occluded Muscular VSD Midmuscular/Apical Perimembranous VSD Restrictive Ventricular Septal Aneurysm VSD rim > 3mm from aortic Valve Defect is <6mm from RV side Presents like a “FUNNEL”

24. The PFM VSD Coil Novel attachment mechanism Stiff distal loops, covered with polyester filaments 5.5F delivery catheter; Distal Coil Diameter: 8,10,12,14 mm

25. Nit Occlud Lê VSD – Deutsche Studie 4 Zentren 35 Fälle eine Heilbehandlung (Köln) Venezuela Dr. Borges 12 Patienten Brasilien Dr. Pedra Dr. Chamie Dr. Simoes Dr. Rossi 28 Patienten Vietnam Dr. Trieu Dr. Nhan Dr. Huan Dr. Hieu Dr. Binh 35 Patienten Thailand Dr. Kritvikrom 14 Patienten Malaysia Dr. Wong Dr. Samion 6 Patienten Argentinien Dr. Granja Dr. Peirone 4 Patienten Saudi Arabien Dr. Galal Dr. Ekram 9 Patienten Ägypten Dr. Sayhed 3 Patienten

26. VSD Coil (Nit-Occlud Le VSD Coil)  Conical-shaped nitinol coil  More flexible, softer and conforms to the shape of VSD  Less traumatic  Used for:  Perimembranous VSD with aneurysmal pouch and muscular VSD  Muscular VSD

27. Shapes of membranous and muscular VSD Courtesy Dr. L. Simoes

28. VSD with VSA formation

31. Occlusion of VSD using the PFM VSD Coil

32. 117 Patients with restrictive VSD Perim. VSD (n=97) Musc. VSD (n=10) Subpulm. VSD (n=10) International Experience with the PFM VSD Coil

36. Device Displacement: none Device Fracture: none Device Embolization: 2 (transcath. removal within 3 hours) AI: n = 2 (I-II°) TR: n = 2 (II°) Hemolysis: n = 5 4 transient 1 severe, device surgically removed Problems of conduction system: none!

37. Occlusion of VSD using the PFM VSD Coil Coil Selection Distal coil diameter is at least double the minimal diameter (right ventricular opening ) equal or 1-2mm larger than left ventricular diameter of VSD. Distal Loop Diameter: 8 mm 10 mm 12 mm 14 mm Prox. Loop Diameter: 6 mm 8 mm

38. VSD Coil (UP-PGH) experience  5 patients  3y – 29 y  VSD with Ventricular septal aneurysm  1 st case was done 3 years ago  Last 4 cases done 1 year ago  Total occlusion after 1 month  No incidence of heart block, CVA, IE and death

39. The implantation procedure Guidance by TOE or TTE Transvenous implantation

44. PDA device to close VSDs?  Perimembranous VSD which are “conical” (like a PDA type A)  Distance from the aortic valve is >4mm  Amplatz Duct Occluder Nguyen Lan Hieu, MD, PhD  Hanoi Medical University-Vietnam Heart Institute  Performed in some patients in Heart Center

45. Pm VSD (conical)

46. VSD (conical)

52. Summary  TCC of VSD is a complex interventional procedure that can be performed effectively and safely in well selected patients  Muscular VSDs can still be closed by Amplatzer devices  VSD coils are safe in aneurysmatic OR conical perimembranous VSDs and muscular VSD which have a distance from the AV node  Majority of the perimembranous VSDs should be closed by surgery at this time until a better device can be made that will not produce heart block at a higher rate  Long-term follow-up is important

53. Thank you for your attention