vsd device closure

VSD DEVICE CLOSURE

Most common congenital heart disease in both adults and children

Prevalence: 20% in isolation. 30-50% with associated defects

Etiology: Congenital or Acquired Location: Inlet, Outlet, Trabecular,

Perimembranous Size: Small, Moderate, Large

Traditionally surgical closure Lock et al:

1988 6 patients Congenital/Acquired VSD Rashkind double umbrella device A-V wire loop technique

Carminati et al 12 papers until 2006 Success rate: 87-100% Major complicaions: 0-15% Need for PPI: 0-8%

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%

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

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

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%

Adverse events in 29.5% with arrhytmia MC with 13%, new or increased AR in 9.2%, new or increased TR in 9.2%

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%

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%

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

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

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

Skeptics went up in arms Damning the device and the procedure Many radicals suffered Most conservatives survived What almost killed the procedure

“Overenthusiasm”

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

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

Devices UsedQin et al (Am J Cardiol 2008; 101:1781-86)


AAPMVSDO 0 103

Symmetric/Assymmetric MVSDO (SSMA)

398 729

SuccessQin et al (Am J Cardiol 2008; 101:1781-86)


398/412 (96.6%) 832/848 (98.2%)

ComplicationsQin et al (Am J Cardiol 2008; 101:1781-86)


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

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

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

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%)

Devices UsedThakker et al Nageshwar Rao


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

ComplicationsThakker et al Nageshwar Rao


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

ECG ChangesThakker et al Nageshwar Rao


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

Follow upThakker et al Nageshwar Rao


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

Post infarct VSD Grave prognosis Mortality:

Medical: 90%(30 days) 97%(1 year) Surgery: 47%(30 days) 53%(1 year)

Device favourable to surgery

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

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%

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

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

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!

Indications for VSD closureLV overload

Z-score of LVEDD > +2

Indications for VSD closureDoppler gradients across the VSD to estimate RV pressure

Indications for VSD Closure

RV pressure? Reversible PHT?

INDICATIONS FOR VSD CLOSUREQP:QS

Qp/Qs can be estimated by using 2D echo and spectral Doppler measurements

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?

Which VSD is suitable for device closure?Location

Echocardiographic delineation of pmVSD

Perimembraneous VSD

Supracristal (=doubly committed/subpulmonary/conal/ infundibular/outlet/subarterial) VSD

Membraneous/PerimembraneousVSD

Lynch P

Subpulmonary= supracristal

inlet

Echocardiographic delineation of various VSDsNot suitable for Device closure basedon location assessedby echo


Look at: Indication for closure? Location of defect Size of defect (suitable device

available?) Rims to neighboring structures Contraindications for percutaneous

closure?

• Clamshell, Cardioseal-/ Cardioseal-Starflex– ~ 300 patients

J Lock, Boston

VSD-Closure Devices

Amplatzer Closure Devices• ASD (4-36 mm)

• Post-MI VSD (16-24 mm)• Perimembraneous VSD

• VSD (4-18 mm)

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

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

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)


Look at: Indication for closure? Location of defect Size of defect (Suitable device

available?) Rims to neighboring structures Contraindications for percutaneous

closure?

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

Exclusion criteria for VSD closure

Overriding Aorta (TOF) Aortic cusp prolapse(= malalignment VSD)

prolapse of aortic cusp

Exclusion criteria for VSD closure

Supracristal VSD Inlet VSD

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!

Perimembranous VSD

Device selection Type of the device

Size of the device

Determinants of the Device type Size of the defect

Morphology of the defect

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

Morphology of the defect Presence of TV aneurysm Separation of the defect from the AoV Presence of aortic valve prolapse Extension into the inlet

Presence of TV aneurysm Mandatory for ADO I and Nit Occlud coil

Absence of aneurysm : Need a double disc design (Symmetrical or asymetrical)

• Presence of aneurysm

• PFM coil

• ADO I

Distance from the aortic valve < 3 mm : AAPMVSDO and Nit Occlud

> 3 mm : ADO I, ADO II, AMVSDO, Symmetric devices

• Small defect (5 mm)

• > 3mm separation from the Ao Valve

• ADO II 6 X 4

• Moderate sized defect (7 mm)

• > 3mm separation from the Ao Valve

• ADO I 10 X 8

• Moderate sized defect (8 mm)

• < 3mm separation from the Ao Valve

Presence of Ao Valve prolapse Severity of prolapse

Presence and severity of AR

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)

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

Muscular VSD

Devices used

Type of device Size of the defect

Morphology of the defect

Size of the defect ADO II: upto 5.5 mm Nit Occlud: upto 8 mm ADO I: Upto 12 mm AMVSDO: Upto 16 mm

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

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

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

Choosing the device size No definite rule Echocardiographic Vs angiographic LV diameter Vs RV diameter 1-2 mm > than the measured diameter

Limitations Protrusion into the LVOT Interference with aortic and tricuspid

valve mechanisms CHB

Biggest concern

COMPLETE HEART BLOCK 0 – 5% Smaller children (< 8 kg) Large defects Inlet extension Associated Down’s syndrome

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%

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

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

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

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

ADO I - Strengths Smaller access CHB has not been reported Less expensive

Choosing the size Echo Vs Angiographic Minimum diameter on the RV aspect +

2mm should be the size of the pulmonary end

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

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

ADO II - Advantages Softer (No polyester patch) Wider waist CHB has not been reported Ease of deployment (Arterial side)

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

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

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

Limitations PMVSD < 8 mm at the RV end Aneurysm formation is mandatory Absence of PHT

Courtsey: Trong Phi Li, MD

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

Advantages Waist is broad Used upto 16-17 mm Even in those with PHT

Disadvantages Not designed for PMVSD closure Larger sheath Encroachment on the LVOT and aortic

valve TV mechanism

Exclusion Small children Large VSDs Significant aortic valve prolapse More than mild AR Down’s syndrome Severe PHT

Follow-up after VSD closure- what to look for?

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

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

Major early and late complications →

mainly complete AV block!

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

The day after the procedure: • ECG • TTE • Chest X-ray Discharged on: • ASS 100 mg/die • Prophylaxis against infective

endocarditis (IE)

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

vsd device closure

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