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VSD DEVICE CLOSURE
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Most common congenital heart disease in both adults and children
Prevalence: 20% in isolation. 30-50% with associated defects
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Etiology: Congenital or Acquired Location: Inlet, Outlet, Trabecular,
Perimembranous Size: Small, Moderate, Large
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Traditionally surgical closure Lock et al:
1988 6 patients Congenital/Acquired VSD Rashkind double umbrella device A-V wire loop technique
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Carminati et al 12 papers until 2006 Success rate: 87-100% Major complicaions: 0-15% Need for PPI: 0-8%
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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%
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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
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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
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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%
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Adverse events in 29.5% with arrhytmia MC with 13%, new or increased AR in 9.2%, new or increased TR in 9.2%
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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%
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Study Bass et al
Thanopoulos et al
Pedra et al
Miro et al Fu et al
Year 2003 2003 2004 2005 2006No. of patients
27 10 10 54 35
Age in yrs 1.25 - 32 1.5 - 12 6 - 32 0.5 - 61 1.2 - 54.4Weight 8.5-80 kg 11-49 kg 19-80 kg 6-77 kg 8-110 kgQp: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%
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Study Bass et al Thanopoulos 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%) 1AR 2 0 0 1 12%LBBB/RBBB
1 3 LBBB 1 NR NR
Hemolysis 0 0 0 2 2Others 1 0 LVOTO-2 0 2
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Study EuropeanRegistry
Butera et al
Predsecu et al
Year 2007 2007 2008No. 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
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Study EuropeanRegistry
Butera et al
Predsecu et al
Residual shunt
NA 1/104 0/20
CHB 16/430 (3.7%)
6/104 (5.7%)
4/20 (20%)
AR 14 (2) 0 0LBBB/RBBB
10 3 0
Hemolysis 5 (1.2% 0 0Others NA 3
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Skeptics went up in arms Damning the device and the procedure Many radicals suffered Most conservatives survived What almost killed the procedure
“Overenthusiasm”
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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
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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
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Devices UsedQin 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
SuccessQin 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%)
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ComplicationsQin 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
LBBBRBBBJunctional rhythm
1016
61532
CHB 6 (Recovered in 3 weeks, No PPI)
5 (2 requiring PPI)
7 not requiring Sx
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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
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VSD typesThakker et al
Nageshwar Rao et al
Jayrangnath et al
Dalvi et al
Perimembranous
310 108 136 76
Muscular 83(34) 38(4) 18(0) 22(3)
Postop (Residual)
2 8 4 1
Others 2 (Subpulmonic)
0 0 0
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ApproachThakker et al Nageshwar Rao
et alJayrangnath 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%)
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Devices UsedThakker et al Nageshwar Rao
et alJayrangnath 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
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ComplicationsThakker et al Nageshwar Rao
et alJayrangnath 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
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ECG ChangesThakker et al Nageshwar Rao
et alJayrangnath 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
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Follow upThakker et al Nageshwar Rao
et alJayrangnath 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
Thromboembolism
0 0 0 0
Pericardial effusion
0 0 0 0
Residual Shunt
13 10 2 3
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Follow upThakker et al Nageshwar Rao
et alJayrangnath 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
Thromboembolism
0 0 0 0
Pericardial effusion
0 0 0 0
Residual Shunt
13 10 2 3
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Post infarct VSD Grave prognosis Mortality:
Medical: 90%(30 days) 97%(1 year) Surgery: 47%(30 days) 53%(1 year)
Device favourable to surgery
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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
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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%
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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
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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
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Indications 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 andPVR < 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
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Indications for VSD closureSigns 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 treatment!
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Indications for VSD closureLV overload
Z-score of LVEDD > +2
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Indications for VSD closureDoppler gradients across the VSD to estimate RV pressure
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Indications for VSD Closure
RV pressure? Reversible PHT?
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INDICATIONS FOR VSD CLOSUREQP:QS
Qp/Qs can be estimated by using 2D echo and spectral Doppler measurements
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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?
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Which VSD is suitable for device closure?Location
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Echocardiographic delineation of pmVSD
Perimembraneous VSD
Supracristal (=doubly committed/subpulmonary/conal/ infundibular/outlet/subarterial) VSD
Membraneous/PerimembraneousVSD
Lynch P
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Subpulmonary= supracristal
inlet
Echocardiographic delineation of various VSDsNot suitable for Device closure basedon location assessedby echo
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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?
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• Clamshell, Cardioseal-/ Cardioseal-Starflex– ~ 300 patients
J Lock, Boston
VSD-Closure Devices
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Amplatzer Closure Devices• ASD (4-36 mm)
• Post-MI VSD (16-24 mm)• Perimembraneous VSD
• VSD (4-18 mm)
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Which VSD is suitable for device closureSuitable 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
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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
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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)
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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?
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Exclusion criteria for percutanous VSD closure
Overriding aorta (malalignment VSD) Supracristal/ inlet VSD Associated significant aortic regurgitation Prolapse of aortic cusp Sub-aortic stenosis Sub-pulmonary stenosis Eisenmenger syndrome
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Exclusion criteria for VSD closure
Overriding Aorta (TOF) Aortic cusp prolapse(= malalignment VSD)
prolapse of aortic cusp
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Exclusion criteria for VSD closure
Supracristal VSD Inlet VSD
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Take home messageSuitability for VSD closureSuitable 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!
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Perimembranous VSD
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Device selection Type of the device
Size of the device
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Determinants of the Device type Size of the defect
Morphology of the defect
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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
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Morphology of the defect Presence of TV aneurysm Separation of the defect from the AoV Presence of aortic valve prolapse Extension into the inlet
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Presence of TV aneurysm Mandatory for ADO I and Nit Occlud coil
Absence of aneurysm : Need a double disc design (Symmetrical or asymetrical)
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• Presence of aneurysm
• PFM coil
• ADO I
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Distance from the aortic valve < 3 mm : AAPMVSDO and Nit Occlud
> 3 mm : ADO I, ADO II, AMVSDO, Symmetric devices
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• Small defect (5 mm)
• > 3mm separation from the Ao Valve
• ADO II 6 X 4
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• Moderate sized defect (7 mm)
• > 3mm separation from the Ao Valve
• ADO I 10 X 8
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• Moderate sized defect (8 mm)
• < 3mm separation from the Ao Valve
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Presence of Ao Valve prolapse Severity of prolapse
Presence and severity of AR
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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)
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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
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Muscular VSD
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Devices used
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Type of device Size of the defect
Morphology of the defect
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Size of the defect ADO II: upto 5.5 mm Nit Occlud: upto 8 mm ADO I: Upto 12 mm AMVSDO: Upto 16 mm
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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
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AMPLATZER Membranous VSD Occluder
Self-expandable Nitinol mesh with polyester patches Non-concentric design to avoid interference with the aortic
valve Sizes: 4 -18mm
Device Size (Waist = A)Right Ventricular Disc (B)Left Ventricular Disc (C)
Device Size(Waist = A)
4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
RV Disc (B) 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
LV Disc (C) 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
Legend
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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
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Choosing the device size No definite rule Echocardiographic Vs angiographic LV diameter Vs RV diameter 1-2 mm > than the measured diameter
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Limitations Protrusion into the LVOT Interference with aortic and tricuspid
valve mechanisms CHB
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Biggest concern
COMPLETE HEART BLOCK 0 – 5% Smaller children (< 8 kg) Large defects Inlet extension Associated Down’s syndrome
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Study Bass et al
Thanopoulos et al
Pedra et al
Miro et al Fu et al
Year 2003 2003 2004 2005 2006No. of patients
27 10 10 54 35
Age in yrs 1.25 - 32 1.5 - 12 6 - 32 0.5 - 61 1.2 - 54.4Weight 8.5-80 kg 11-49 kg 19-80 kg 6-77 kg 8-110 kgQp: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%
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Study Bass et al Thanopoulos et al
Pedra et al
Miro et al Fu et al
Residual shunt
8% 0% 10% 17% 4%
CHB 0 0 0 3+2 1AR 2 0 0 1 12%LBBB/RBBB
1 3 TLBBB 1 NR NR
Hemolysis 0 0 0 2 2Others 1 0 LVOTO-2 0 2
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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
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AMPLATZER® Membranous VSD Occluder 2Device 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
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94
ADO I
Model / Reorder Number
[A] Device Diameter at Descending Aorta (mm)
[B] Device Diameter at Pulmonary Artery (mm)
[C] Retention Skirt (mm)
[D] Length (mm)
Recommended Sheath Size (with AMPLATZER TorqVue Delivery System)
9-PDA-003 5 4 9 5 5 F, 180° Curve
9-PDA-004 6 4 10 7 6 F, 180° Curve
9-PDA-005 8 6 12 7 6 F, 180° Curve
9-PDA-006 10 8 16 8 6 F, 180° Curve
9-PDA-007 12 10 18 8 7 F, 180° Curve
9-PDA-008 14 12 20 8 7 F, 180° Curve
9-PDA-009 16 14 22 8 7 F, 180° Curve
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ADO I - Strengths Smaller access CHB has not been reported Less expensive
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Choosing the size Echo Vs Angiographic Minimum diameter on the RV aspect +
2mm should be the size of the pulmonary end
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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
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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
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ADO II - Advantages Softer (No polyester patch) Wider waist CHB has not been reported Ease of deployment (Arterial side)
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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
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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
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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
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Limitations PMVSD < 8 mm at the RV end Aneurysm formation is mandatory Absence of PHT
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Courtsey: Trong Phi Li, MD
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AMPLATZER Muscular VSD Occluder
108
Self-expandable Nitinol mesh with polyester patches conform to the ventricular septum
Waist length: 7mm Sizes: 4-18mm
Device Size (Waist = A)Right Ventricular Disc (B)Left Ventricular Disc (C) Length of Waist (D)
Legend
Device Size (Waist = A) 4 6 8 10 12 14 16 18RV Disc (B) 9 14 16 18 20 22 24 26LV Disc (C) 9 14 16 18 20 22 24 26Length of Waist (D) 7 7 7 7 7 7 7 7
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Advantages Waist is broad Used upto 16-17 mm Even in those with PHT
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Disadvantages Not designed for PMVSD closure Larger sheath Encroachment on the LVOT and aortic
valve TV mechanism
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Exclusion Small children Large VSDs Significant aortic valve prolapse More than mild AR Down’s syndrome Severe PHT
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Follow-up after VSD closure- what to look for?
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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
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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
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Major early and late complications →
mainly complete AV block!
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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
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The day after the procedure: • ECG • TTE • Chest X-ray Discharged on: • ASS 100 mg/die • Prophylaxis against infective
endocarditis (IE)
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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 stenosis/DCRV