Based on the size of the defect, perimembranous VSDs between 4-18 mm in diameter would be suitable for closure with the Amplatzer VSD occluder. The device size would need to be selected based on the actual defect size as assessed by echocardiography. Adequate rims around the defect are required but specifics on rim measurements are not provided in this document. Other factors such as indications for closure and no contraindications to the percutaneous approach would also need to be evaluated for a particular patient.
5. Carminati et al
12 papers until 2006
Success rate: 87-100%
Major complicaions: 0-15%
Need for PPI: 0-8%
6. Carminati et al
European VSD registry
430 patients , ITT, 23 referral hospitals
119 muscular, 250 membranous, 16 multiple,
45 post op
Multiple devices
Overall success rate: 95.3%
7. Early complication: 12.7%
Significant complication: 6.5%
Death: 0.2%
Device embolosation: 0.9%
Tachyarrhytmia:0.7%
Early CHB: 2.8%. 6 during procedure, 6 within
one week, all in PM VSD
8. Butera et al
104 patients, PM VSD, Single centre
CHB in 9 patients , PPI in 6 patients
Multivariate analysis: Age a risf factor for CHB
with a RR of 0.25
Only noted in children less than 6 years of age
9. Holtzer et al
Large International registry of PM VSD using
Amplatzer device
100 patients
Procedural success: 93%
Immediate complete closure:58.1% with <2mm
shunt in 95.7%
10. Adverse events in 29.5% with arrhytmia MC
with 13%, new or increased AR in 9.2%, new
or increased TR in 9.2%
11. Chinese series
2079 patients, mostly PM VSD
Amplatzer or Chinese Symmetric/Asymmetric
devices
Procedural success: 98.6%
Residual shunt >2mm in 0-4.7%
Adverse events in 2.5-19.3%, CHB in 0.1-
7.6%, PPI in 0.2%
12. Study Bass et
al
Thanopou
los et al
Pedra et
al
Miro et al Fu et al
Year 2003 2003 2004 2005 2006
No. of
patients
27 10 10 54 35
Age in yrs 1.25 - 32 1.5 - 12 6 - 32 0.5 - 61 1.2 - 54.4
Weight 8.5-80 kg 11-49 kg 19-80 kg 6-77 kg 8-110 kg
Qp:Qs 1.6 1.93±0.29 1.5-5.5(2) 1.7±0.6 (1.8)
Device
size (mm)
4-12 4-8 8-18 6-18 6-16
Successful
implant
93% 100% 100% 94% 91%
13. Study Bass et al Thanopou
los et al
Pedra et
al
Miro et al Fu et al
Residual
shunt
2/27 0/10 1/10 9/54 1/35
CHB 0 0 0 3+2 (10%) 1
AR 2 0 0 1 12%
LBBB/RB
BB
1 3 LBBB 1 NR NR
Hemolysis 0 0 0 2 2
Others 1 0 LVOTO-2 0 2
14. Study European
Registry
Butera et
al
Predsecu
et al
Year 2007 2007 2008
No. of
patients
430 104 20
Age in yrs 8 (0.4 to
70 years)
14 (0.6-63
years)
1.6 (0.5 –
16.2
years)
Weight in
kg
28 (4-124
kg)
26.5 (6.5
– 96 kg)
9.7 (6.2-
43 kg)
Qp:Qs 2.1 (1-8) 2 (1.3-5)
Device
size (mm)
7 (3-22) 8 (4-16)
Successful
implant
410/435
(95%)
100/104
(96.2%)
20/20
(100%)
Game Changers
16. Skeptics went up in arms
Damning the device and the procedure
Many radicals suffered
Most conservatives survived
What almost killed the procedure
“Overenthusiasm”
17. Introspection
Patient selection
Problems with AAPMVSDO
Short waist 2 mm
Stiff discs
High “clamp force”
Device selection
PFM Le coils
ADO I
ADO II
Modified devices
18.
19. Qin et al (Am J Cardiol
2008; 101:1781-86)
Yang et al (Eur Heart J
2010; 31:2238-45)
Period of Study 2002-2005 2002-2008
Total no of cases 412 848
Age 16.4 ± 9.1 years 9 (2-73 years)
Gender (M:F) 202 : 210 426 : 406
Weight 30.5 (10-88)
Basic Data
20. Devices Used
Qin et al (Am J Cardiol
2008; 101:1781-86)
Yang et al (Eur Heart J 2010;
31:2238-45)
AAPMVSDO 0 103
Symmetric/Assymmetric
MVSDO (SSMA)
398 729
Success
Qin et al (Am J Cardiol
2008; 101:1781-86)
Yang et al (Eur Heart J 2010;
31:2238-45)
398/412 (96.6%) 832/848 (98.2%)
21. Complications
Qin et al (Am J Cardiol
2008; 101:1781-86)
Yang et al (Eur Heart J
2010; 31:2238-45)
Device Embolization 3 (2 retrieved and
redeployed)
2 (Surgical removal)
NeoAR 3 (device removed) 1 (Requiring Sx)
NeoTR 1 (Device removed) 1 (Requiring Sx)
Residual shunt 0 405
LBBB
RBBB
Junctional rhythm
10
16
6
15
32
CHB 6 (Recovered in 3 weeks, No
PPI)
5 (2 requiring PPI)
7 not
requirin
g Sx
22. Thakker et al Nageshwar Rao
et al ( CCVI
2011; 77:252-
59), (JACC 2012;
60:2421-22)
Jayrangnath et
al
Dalvi et al
(CCVI 2006;
68:145-52),
(CCVI 2006;
68:620-28)
Period of
Study
2007-2012 2006-2012 2010-2012 2000-2012
Total no of
cases
431 158 158 102
Age 1 year to 38
years (7.6
years)
6m to 22 years
(4.6 years)
9m to 41 years
(5.3years)
11m to 21 years
(4.2 years)
Gender (M:F) 255:176 71:87 91:67 68:34
Weight 8.2 – 72 (20) 6.2 – 55 (14) 7.5 – 64 (21) 7.7 - 56 (16)
Basic Data
23. VSD types
Thakker et
al
Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Perimembrano
us
310 108 136 76
Muscular 83(34) 38(4) 18(0) 22(3)
Postop
(Residual)
2 8 4 1
Others 2
(Subpulmoni
c)
0 0 0
24. Approach
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Transvenous 397 64 112 85
Transarterial 0 94 46 14
Hybrid 34 4 0 3
Success 423/431
(98.1%)
150/158 (95%) 157/158
(99.3%)
100/102 (98%)
25. Devices Used
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
AAPMVSDO 1 19 12 61
Symmetric
VSDO
113(SSM) +
159 (Starway)
11 (Lifetech) 0 0
MVSDO 32 20 8 15
ADO I 88 18 90 11
ADO II 0 87 46 14
ASO 1 0 2 0
26. Complications
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Device
Embolization
4 3 1 1
NeoAR 4 (1) 3 1 6
NeoTR 3 2 5 12 (1)
Acute MR 0 1 (1) 0 0
Hypotension 0 2 0 1
CHB 5 0 1 0
27. ECG Changes
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Isorrhythmic
AVD
7 0 2 1
RBBB 6 9 2 6
LBBB 2 0 0 1
IRBBB 0 0 0 3
LAHB 1 0 0 3
28. Follow up
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Duration 1-54 months 1-56 months 1-30 months 1-134 months
Late onset
CHB
0 0 0 0
Device
migration
0 0 0 0
Thromboemb
olism
0 0 0 0
Pericardial
effusion
0 0 0 0
Residual
Shunt
13 10 2 3
29. Follow up
Thakker et al Nageshwar Rao
et al
Jayrangnath et
al
Dalvi et al
Duration 1-54 months 1-56 months 1-30 months 1-134 months
Late onset
CHB
0 0 0 0
Device
migration
0 0 0 0
Thromboemb
olism
0 0 0 0
Pericardial
effusion
0 0 0 0
Residual
Shunt
13 10 2 3
30. Post infarct VSD
Grave prognosis
Mortality:
Medical: 90%(30 days) 97%(1 year)
Surgery: 47%(30 days) 53%(1 year)
Device favourable to surgery
31. Holtzer et al
US registry of Amplatzer PI VSD
18 patients, 5 acute, 13 subacute
Success: 89%
Mortality: 25 % (30 days)
20% moderately large shunt on follow up
32. Thielle et al
Amplatzer device in acute MI VSD
29 patients, cardiogenic shock in 55%
Success: 86%
Mortality:
Overall: 35% (30 days)
CS: 88%
Non CS: 35%
33. Which VSD is suitable for device
closure?
Look at:
Indication for closure
Location of defect
Size of defect
Rims to neighboring structures
Contraindications for percutaneous
closure
34. Which VSD is suitable for device
closure?
Look at:
Indication for closure
Location of defect
Size of defect
Rims to neighboring structures
Contraindications for percutaneous
closure
35. dications for VSD Closure
Relevant shunt:
Qp/Qs > 2 : 1 and LV volume overload
Qp/Qs > 1.5 : 1* and
PA pressure < 2/3 of systemic pressure and
PVR < 2/3 of systemic Vascular resistance
Qp/Qs > 1.5 : 1 and
LV systolic or diastolic failure
History of endocarditis
*CCS Guidelines 2006, AHA Guidelines 2008 /ESC 2012
36. Indications for VSD closure
Signs for small VSD
Asymptomatic
Echo:
High velocity jet through VSD
No LV volume overload
No pulmonary hypertension
Catheterization:
Qp:Qs < 1.5
Mean pulmonary artery pressure < 25 mmHg
Low PVR < 200 dyn.s.cm-5
Many VSDs are small and do not require
41. Which VSD is suitable for device
closure
Look at:
Indication for closure?
Location of defect
Size of defect
Rims to neighboring structures
Contraindications for percutaneous
closure?
42. Which VSD is suitable for device closure?
Location
43. Echocardiographic delineation of pmVSD
Perimembraneous VSD
Supracristal
(=doubly committed/subpulmonary/conal/
infundibular/outlet/subarterial) VSD
Membraneous/
Perimembraneous
VSD
Lynch P
46. Which VSD is suitable for device
closure
Look at:
Indication for closure?
Location of defect
Size of defect (suitable device
available?)
Rims to neighboring structures
Contraindications for percutaneous
closure?
49. Which VSD is suitable for device closure
Suitable device for defect? rims?
• Diameters 4 – 18 mm central
waist (1 mm increments)
• Waist: same size or 1 mm >
defect
• Rim between defect/aortic
valve ≥ 2mm
Amplatzer pmVSD
PFM VSD coil •Effective defect diameter ≤ 8mm
•No aortic rim required
•Aneurysm preferable
50. Which VSD is suitable for device closure
Suitable device for defect? rims?
• Waist diameters: 4-18 mm
(2 mm increments)
• Waist: 7 mm; Discs:
Waist + 8 mm
(surrounding rim ≥ 4mm)
• Waist should be 1-3 mm
larger than the largest
diameter of the VSD
Amplatzer muscular VSD occluder
51. Which VSD is suitable for device closure
Suitable device for defect? rims?
Not suitable based on
echocardiographic assessment:
Defect diameter too large (no
appropriate device available)
Rims too small or even absent (e.g. rim
to aortic valve)
52. Which VSD is suitable for device
closure
Look at:
Indication for closure?
Location of defect
Size of defect (Suitable device
available?)
Rims to neighboring structures
Contraindications for percutaneous
closure?
56. Take home message
Suitability for VSD closure
Suitable for Device closure
Adequate indication for
closure
Location:
perimembraneous/
muscular
Diameter suitable for
device closure
Adequate rims to
neighboring structures
(device dependent)
No contraindication for
VSD closure
Not suitable for device closure
No indication for closure
Location: supracristal /
inlet
Diameter too large for
device closure
Missing/absent rims to
neighboring structures
(device dependent)
Contraindications for
VSD closure present
(e.g. AV prolapse ± AR(
malalignment VSD)
Decision for suitability of VSD closure can be made by echo!
60. Determinants of the Device type
Size of the defect
Morphology of the defect
61. Size of the defect
ADO II : upto 5.5 mm
Nit Occlud Le VSD coil : upto 8 mm
ADO I : upto 12 mm
AAPMVSDO & AMVSD occluder : upto 16 mm
Modified Membranous VSD occluders
(Lifetech and Shanghai Steel Corp) : upto 19
mm
62. Morphology of the defect
Presence of TV aneurysm
Separation of the defect from the AoV
Presence of aortic valve prolapse
Extension into the inlet
63. Presence of TV aneurysm
Mandatory for ADO I and Nit Occlud coil
Absence of aneurysm : Need a double disc
design (Symmetrical or asymetrical)
66. Distance from the aortic valve
< 3 mm : AAPMVSDO and Nit Occlud
> 3 mm : ADO I, ADO II, AMVSDO, Symmetric
devices
67. • Small defect (5 mm)
• > 3mm separation from the Ao Valve
• ADO II 6 X 4
68. • Moderate sized defect (7 mm)
• > 3mm separation from the Ao Valve
• ADO I 10 X 8
69. • Moderate sized defect (8 mm)
• < 3mm separation from the Ao Valve
70. Presence of Ao Valve prolapse
Severity of prolapse
Presence and severity of AR
71. Extension into the inlet
Use a device with a minimum clamp force
Coil (Nit Occlud) or a single disc design (ADO
I)
Devices with wider waist (ADO II, AMVSDO,
Modified devices)
72. Sizing the device
No definite guidelines
Echo Vs Angio
LV Vs RV
APMVSDO: RV side of the defect. Measure in
two planes. Average and add 1
ADO I: RV side of the defect + 1 or 2 =
Pulmonary end of the ADO I
ADO II: RV side of the defect + 0.5 to 1 mm
76. Size of the defect
ADO II: upto 5.5 mm
Nit Occlud: upto 8 mm
ADO I: Upto 12 mm
AMVSDO: Upto 16 mm
77. Morphology of the defect
Simple : Point of entry and exit are opposite
each other – Any of the devices
Complex : Coursing within the IVS – ADO II or
Nit Occlud
83. Strengths
Specifically designed for PMVSDs
Asymmetric design is ideal for preventing
aortic valve injury
Separation from the aortic valve – 2mm
Upto 8 kg
VSD size of upto 16 mm
84. Choosing the device size
No definite rule
Echocardiographic Vs angiographic
LV diameter Vs RV diameter
1-2 mm > than the measured diameter
89. Biggest concern
COMPLETE HEART BLOCK
0 – 5%
Smaller children (< 8 kg)
Large defects
Inlet extension
Associated Down’s syndrome
90. Study Bass et
al
Thanopou
los et al
Pedra et
al
Miro et al Fu et al
Year 2003 2003 2004 2005 2006
No. of
patients
27 10 10 54 35
Age in yrs 1.25 - 32 1.5 - 12 6 - 32 0.5 - 61 1.2 - 54.4
Weight 8.5-80 kg 11-49 kg 19-80 kg 6-77 kg 8-110 kg
Qp:Qs 1.6 1.93±0.29 1.5-5.5(2) 1.7±0.6 (1.8)
Device
size (mm)
4-12 4-8 8-18 6-18 6-16
Successful
implant
93% 100% 100% 94% 91%
91. Study Bass et al Thanopou
los et al
Pedra et
al
Miro et al Fu et al
Residual
shunt
8% 0% 10% 17% 4%
CHB 0 0 0 3+2 1
AR 2 0 0 1 12%
LBBB/RB
BB
1 3 TLBBB 1 NR NR
Hemolysis 0 0 0 2 2
Others 1 0 LVOTO-2 0 2
92. AMPLATZER Membranous VSD Occluder 2
Conforms to the Ventricular Anatomy
The concave left ventricular (LV) disc is shaped to
conform with the septal wall
The compliant outer waist allows the device to
conform to the shape of the defect
Minimizes Pressure on the Septal Tissue1
The 3 mm waist length reduces clamp force on the
ventricular septum
Promotes Closure and Stability
Polyester-filled waist and discs promote closure of
the defect
Concave, oval-shaped LV disc promote stability
93. AMPLATZER® Membranous VSD Occluder 2
Device Sizes
18 available sizes:
9 waist diameters: 4-10,12,14mm
2 rims: 1mm & 3mm
All sizes have a 3 mm waist length
Rim
Waist Diameter
Waist Length
95. ADO I - Strengths
Smaller access
CHB has not been reported
Less expensive
96. Choosing the size
Echo Vs Angiographic
Minimum diameter on the RV aspect + 2mm
should be the size of the pulmonary end
97. Limitations
Was not designed for PMVSD
Only those with a good TV aneurysm
Separation from the aortic valve – 4-5 mm
PMVSD upto 12 mm at the RV end
Aortic retention disc encroaching on the AV
Interference with the TV mechanism
Severe PHT
98.
99.
100. ADO II Specifications
Model /
Reorder
Number
[A] Waist
Diameter
(mm)
[B] Device
Length
(mm)
[C] Disc
Diameter
(mm)
Recommended Catheter Size (with
AMPLATZER TorqVue LP Delivery
System)
9-PDA2-03-04 3 4 9 4 F
9-PDA2-03-06 3 6 9 4 F
9-PDA2-04-04 4 4 10 4 F
9-PDA2-04-06 4 6 10 4 F
9-PDA2-05-04 5 4 11 5 F
9-PDA2-05-06 5 6 11 5 F
9-PDA2-06-04 6 4 12 5 F
9-PDA2-06-06 6 6 12 5 F
.
A C
B
101. ADO II - Advantages
Softer (No polyester patch)
Wider waist
CHB has not been reported
Ease of deployment (Arterial side)
102. Limitations
Not designed for PMVSD: length is an issue
Separation from the aortic valve – 4 mm
Modifications in the delivery system
Close VSDs only upto 5 to 5.5 mm
Encroachment on the aortic valve and LVOT
Impairment of TV mechanism
103.
104. Nit-Occlud Le VSD coil
Coil design with attached polyester fibres
Outstanding adaptation properties
Broad range of different sizes (8 – 16 mm
distal diameter)
Small delivery system (6 to 7 Fr)
No CHB reported – High flexibility
105. Device Selection
Distal diameter (D) at least twice the minimal
diameter of the VSD on the right ventricular
side and 1–2 mm greater than, the diameter of
the VSD at the LV side.
P = proximal, D = distal
106. Limitations
PMVSD < 8 mm at the RV end
Aneurysm formation is mandatory
Absence of PHT
114. Major complications
Complete AV block
• Aortic-/ Tricuspid valve dysfunction
• Malposition/embolization of device
• Residual defect (severe)
• Severe hemolysis
Carminati M et al.European H J 2007, 28:
2361
Kenny D et al: Catheter Cardiovasc Interv
2009, 73:568-75
115. Minor complications
Transient arrythmias
• Residual defect (small)
• Transient hemolysis
• Inguinal hematoma and fistula
Carminati M et al.European H J 2007, 28:
2361
Kenny D et al: Catheter Cardiovasc Interv
2009, 73:568-75
116. Major early and late
complications →
mainly complete AV
block!
117. Relationship between VSD and
conduction system
The conduction tissue is primarily placed postero-inferiorly with reference to
membraneous VSDs, while it is placed antero-superiorly in most of the muscular VSDs
Lynch PJ. C Carl Jaffe Yale University
118. The day after the procedure:
• ECG
• TTE
• Chest X-ray
Discharged on:
• ASS 100 mg/die
• Prophylaxis against infective endocarditis
(IE)
119. 1, 6, 12, 24 months, then every 2nd year
•Symptoms?
–dizziness, syncope, dyspnea, hemolytic
anemia ...
•Murmurs?
• ECG- abnormalities?
•TTE (TEE if required):
Residual defect? Tricuspid valve dysfuntion?
AR? RVOT/LVOT obstruction?Device
malposition?
Development of discrete subaortic
Notas do Editor
Bedenken beim Verschluss: 3% Periprozedurales Risiko steht 0, 5% Risiko einer bakteriellen Endokarditis entgegen!!!
Suitable for device closure: pmVSD, mid-muscular and apical VSD
Supracristal (or doubly committed) ventricular septal defect (VSD) is the least common type of VSD in the Western Hemisphere, accounting for approximately 5-7% of such defects in this part of the world, including in the United States.[1] The location of the supracristal VSD, with its close proximity to the aortic root, accounts for the common development of aortic insufficiency with this defect. Left-to-right shunting of blood through the defect is believed to progressively pull aortic valve tissue (especially the right coronary cusp) through a Venturi effect The crista supraventricularis can be considered synonymous with the infundibular (or conus) ventricular septum. It is the portion of the septum that separates the tricuspid and pulmonary valves. Defects above this part of the septum are referred to as supracristal defects. The term is generally reserved for defects lying immediately under the pulmonary valve. A defect, usually small, may occur within the conus septum, and, technically can be termed supracristal. Supracristal VSDs make up approximately 5-7% of VSDs in the Western Hemisphere, but they are the most common VSD in some Asian populations, making up 25% of all VSDs in patients in the Eastern Hemisphere. Alternate nomenclature systems refer to this VSD as conal, outlet, subarterial, or infundibular. Supracristal VSDs lie just beneath the pulmonary and aortic valve annuli. Because of the anatomic location and Venturi effect from VSD flow, prolapse of the right coronary cusp of the aortic valve into the defect may result in significant aortic insufficiency
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