includes PBPV and TPVI

1. Percutaneous
PulmonaryValveInterventions
Dr.N.Praveen
DM Cardiology Final yr PG
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2. Introduction
• Pulmonary valve is intervened till recent times surgically as part of
repair of congenital heart defects.
• Percutaneous Valvotomy developed wayback in 1950s with
changes in profile of balloons and less complications with
improvement in technology.
• The implantation of the valve percutaneously was successful in
2000, creating an innovation in treatment of valvular heart disease.
• TPVI is on uprise still in phase III trials,with only one valve in the
armamentarium compared to almost 45 percutaneous valves for the
aortic valve.
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3. Anatomy of pulmonary valve
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5. Causes of pulmonary valve disease
• Acquired pulmonary valve disease in the adult population is unusual
and mostly relates to rarities such as carcinoid disease.
• Even though rheumatic heart disease is common, pulmonary valve is
the least affected one(rare).
• Infective endocarditis is on uprise as there are increased cases of IV
drug abuse and CKD patients on dialysis.
• Congenital heart diseases mostly assosciated with dysfunction of
pulmonary valve either as a primary component or post repair.
• Surgical revision of RVOT is commonly performed in this population.
• Repeated operations are most likely with increased mortality being
added with repeat surgery if surgical correction done at an early age.
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6. Pulmonary valve stenosis
• First described by John Baptist Morgagni(1761).
• 8-10% of all congenital heart diseases.
• MC form – valve is dome shaped,2-4 raphes present but no separation
into valve leaflets.
• Trileaflet dysplastic myxomatous valve stenosis (15%) , they have no
commissural fusion.
• Valve annulus hypoplasia
• Commonly seen in patients with Noonan’s syndrome.
• Secondary changes are – RVH,TR and RV failure.
• Post stentotic dilation is usually seen in MPA –can extend into LPA.
• Usually asymptomatic – exercise intolerance MC symptom.
• Systolic ejection click and Ejection systolic murmur heard at left
upper sternal border.
• Confrimation of severity – Echo – gradient,RVH,RV pressures.
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7. Percutaneous Balloon
Pulmonary Valvuloplasty
PBPV
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8. Pulmonary valvuloplasty -- Surgical to
Transcatheter
• Mechanical valve dilatation
• Brock procedure(valvulotomy)
• Bougies
• Direct incision of fused pulmonary commissures under
cardiopulmonary bypass.
• PS - First congenital lesion to be treated with balloon dilation.
• Angiographic balloon catheter
• Single balloon technique
• Inoue balloon
• Tyshak balloon
• Double balloon technique
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10. • Balloon dilatation of valvar pulmonic stenosis by a pullback or
dynamic technique was described by Rubio and Limon-Lason in
1954.
• Semb et al. in 1979,
• Technique of static dilatation as it is used now was originally
described by Kan et al in 1982.
1.Rubio V, Limon Lason R: Treatment of pulmonary valvar stenosis and tricuspid stenosis using a
modified catheter. Second World Congress on Cardiology, Washington, DC, 1956,
2.Semb BKH, Tijonneland S, Stake G, Aabyholm G: “Balloon valvulotomy ” of congenital
pulmonary valve stenosis with tricuspid valve insufficiency. Cardiovasc Radio1 2,239 (1979)
3.Kan JS, White RI Jr, Mitchell SE, Gardner TJ: Percutaneous balloon valvuloplasty : A new
method for treating congenital pulmonary valve stenosis. N Engl J Med 307, 540 (1982).
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12. • Technique remain unchanged,but the profiles of balloon changed.
• Procedural success is >95% in children and adults with congenital
pulmonary stenosis.
• Residual gradient of <35 mmHg in >75% of patients.
• Complications occur in <5%
• Femoral vein injury
• VPCs
• Pulmonary annular rupture – children
• Death - rare
• Recurrence of stenosis with need for intervention < 15%.
• Mild pulmonary insufficieny is seen upto 65%
• Moderate,severe PR - < 7% .
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13. Indications
• Moderate or severe symptomatic Congenital pulmonary valve
stenosis
• Severe Bicuspid pulmonary valve stenosis.
• As a palliative procedure before surgical correction in TOF.
• Can be done in neonates,infants,adolescents,adults.
Not suitable
• Dysplastic valves and pulmonary hypoplasia.
• Primary fibromuscular subvalvular narrowing
• Priamry fibromuscular supravalvular narrowing.
• DCRV
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14. Doppler mean gradient has been shown in one study to correlate better with peak-to-peak
catheterization gradient but is not commonly used.
ACC/AHA VHD GUDIELINES 2014
EAE RECOMMENDATIONS
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15. Key points
• Valvar pulmonary stenosis gradients >40 mmHg with evidence of
RVH
• No evidence for mild PS will benefit from PBPV.
• Dysplastic valve morphology and annular hypoplasia – poor response
to balloon dilation and increased complications.
• Age is not a predictor of response.
• Commissural fusion - mechanical separation of fused
commissures.(not seen in dysplastic valves)
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16. Preprocedural evaluation
• 1.ECG
• 2.2DECHO
• Grading of the pulmonary valve stenosis by echocardiography.
• Peak gradient in the RVOT – subvalvular,valvular,supravalvular.
• Calculation of the pulmonary annulus.
• Morphology of the valve.
• Distal pulmonary arteries size.
• 3.Cardiac catheterization – usually not required for diagnosis.
• Usually done before the procedure of balloon dilation.
• Pullback gradient from distal pulmonary artery to MPA,Pulmonary
valve,subvalvular ,RV.
• RV angiography in AP cranial and lateral.
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20. Patient preparation
• Fasting from the night before procedure
• Local anaesthesia is usually enough.
• General anaesthesia for children.
• Venous access – unilateral or bilateral (8F)
• Unilateral single balloon technique
• Bilateral double balloon technique
• Right femoral artery(6F or 5F) – pressure monitoring – pigtail
catheter is used.
• Inj. Heparin (2500IU) at the start of procedure.
• One dose of broad spectrum antibiotic at the start of procedure.
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21. Defining the anatomy of valve
• Right Heart catheterization - 7F balloon tip wedge catheter through
femoral vein.
• Cardiac index by saturation data or thermodilution technique.
• Pressure pullback gradient – from MPA to RV – systolic
transvalvular gradient.
• An Apex or Rosen 0.035” exchange wire is then positioned in the
RV apex.
• Wedge catheter to be exchanged for a marker pigtail catheter for
angiography of 35cc@ 35 cc/sec.
• The views are AP cranial 15,lateral view.
• Measurement of pulmonary annulus in two views – balloon size
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22. Cook Rosen 0.035*180 cm
curved guide wire
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24. Techniques
• Single balloon or
• Double balloon technique
• No evidence that either technique has a significant advantage
regarding success, development of insufficiency or recurrence of
stenosis.
• Single balloon – less complicated technically
• Cant be used for large pulmonary annuli.
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25. Choosing the balloon size
• Balloon size with >150% the diameter of the normal pulmonary valve
annulus will result in rupture.
Ring JC et al,Am J Cardiol 1985;55(1):210-4.
• Significant improvement in stenosis relief achieved with balloon
diameters more than 100% pulmonary annulus diameter.
Radtke et al,JACC 1986;8(4):909-15.
• The target balloon diameter should be 120-140% of the pulmonary
valve annulus diameter.
• Double balloons if used – total circumference of the two balloons
should be equal to 120-140% of the circumference of the valve
annulus.
• Formula for calculating the double balloon diameter is
1.2(PV annulus diameter)/(2+)
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26. • Ex:
• A 22 mm pulmonary valve
• Single 26 mm diameter balloon
• Two 16 mm diameter balloons.
• Length of the balloon – long enough to allow stable position
across the RVOT ,but not so long such that it protrudes into either
the tricuspid valve proximally or a distal branch pulmonary artery.
• Generally balloons 4 cms long are adequate although occasionally
6 cm are required to maintain position across the valve.
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27. Sheath and wire placement
• Long sheath is not required for PBPV.
• An exchange length relative stiff 0.035” wire – Rosen or
Amplatz – positioned in the distal lower pulmonary artery – 7F
wedge catheter is used for obtaining the position.
• Either the left or right PA can be used although the left provides
a straighter course in most patients.
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28. Preparation of balloon
• Purge of air
• Fill with diluted radiographic contrast.
• Contrast dilution is 1:3 with normal saline.
• Balloon to be inflated to the desired size and crimped with
negative suction by indeflator.
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29. Balloon position and dilation
• Lateral angiogram to be kept as reference.
• Balloon is centered onto the valve and inflated to 6 atm.
• Balloon movement during inflation is common so the catheter must be
maintained in position and the inflation recorded so that it may be
reviewed.
• If no complete resolution of the balloon waist – reposition and the
inflation to be repeated.
• Following dilation the balloon catheter to be exchanged for the wedge
catheter and right heart pull back hemodynamic pressure
measurements to be repeated.
• RV angiogram in AP and lateral projections – dynamic RVOT
stenosis, aneurysm formation or new onset TR..
• Dynamic obstruction will resolve gradually.
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32. Post procedure
• As it is a venous procedure complications are less.
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33. Suicidal Right Ventricle
• Subvalvular hypertrophy causing near obstruction,when PBPV
done at the valve – the reduction in afterload may allow for the
muscular obstruction to be accentuated.
• Subvalvular dynamic obstruction – severe hypotension.
• Called as suicidal RV because subvalvular hypertrophy usually
accompanies the stenosis – increased afterload.
• Rx: Volume expansion
• Beta blockade (IV Propanolo 0.1mg/kg )
• Usually diminish over the weeks with regression of RVH.
• Repeat dilation for the subvalvular gradient is contraindicated.
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34. SERIES ON PBPV
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35. Stanger series
Valvuloplasty andAngioplasty of
CongenitalAnomalies Registry VACA
• 784 patients
• All ages
• Clinical success in 98% patients.
• Procedural mortality was <0.5%
• Average peak gradient fell from 85 to 33 mm Hg.
Am J Cardiol 1990;65:775.
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36. Chen et al
• 53 adolescent and adult patients
• 1985 -1999
• Aged 13-55 yrs
• SPG fell from 91± 46 to 38± 32 mm Hg.
• Follow up – 7 yrs
• Gradient fell further on follow up.
• Pulmonary insufficiency immediately after procedure – 7 out
of 53.
NEJM 1996;335:21
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37. Mc Crindle and JC Kan et al
• Duration of follow up of 4.6± 1.9 yrs.
• 46 patients
• Median age of 4.6 yrs (3 months to 56 yrs)
• June 1981 – 1986
Before PBPV After
RV – PA gradient 70± 36 mm Hg 23± 14 mm Hg
Gradient reduction to <36 mm Hg seen in 41 of 46 pts (89%)
Long term follow up gradients < 36 mm Hg (86%)
Age < 2 yrs at initial PBPV – risk factor for gradients > 36 mm
Hg at follow up
Circulation 1991;83:1915-1922
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38. P.S.Rao et al
• 56 patients
• 36 patients were followed up
• 11 months follow up
• Poor result in 7 patients
• Repeat BPV done in 5 patients
Clin cardiol. 12.,55-74(1989)
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39. Cause of restenosis
• Balloon annulus ration <1.2
• Gradient post procedure >36 mm Hg
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40. Pressure for inflation ?
• The recommendations for pressure of inflation of the balloon
varied between 2 to 8.5 atm and duration of each inflation was
suggested to be 5 to 20 s.
• Anywhere between one to four balloon inflations, 2 to 5 minutes
apart, has been suggested.
• Clearly, no data are available for deciding on which is the best
method of inflation.
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41. TPVI
Transcatheter Pulmonary Valve
Implantation
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42. Introduction
• TPVI has evolved into a viable alternative to surgical conduit or
bioprosthetic valve replacement.
• Paved the way for a more advanced approach to congenital and
structural interventional cardiology.
• Although many successes have been noted, there are still a number of
challenges with this procedure.
• Research is ongoing to broaden the use of this technology when
treating patients with dilated right ventricular outflow tracts,
• Early experience with a selfexpanding valve model has been reported.
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43. Evolution of TPVI
• In 2000,Bonhoeffer et al introduced the concept of tPVR mounted on
a balloon expandable stent in lambs.
• Bovine jugular vein,platinum iridium stent was used.
• Radial diameter expanded to 18mm.
• Internal jugular vein approach(11 lambs)
• Overall success was 36%.
• Human implantation by same group in later part of 2000 same yr.
• A12 yr old M,VSD with pulmonary atresia – significant stenosis
and insufficiency of Edwards SAPIEN valved conduit 18 mm .
• Transfemoral approach.
• PR was effectively relieved.
• 2 yrs later report of 8 patients - valvar competence achieved in
all,stenosis relieved in 3 patients ,stent fractures in 2 patients.
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44. Indications
1.Pulmonary Regurgitation
2.Failing bioprosthesis
• RVOT or MPA diameter < 22 mm in diameter
• RV Pressures > 2/3 systemic
• RV dilation
• Symptoms of exercise intolerance
3.Valve implant is appropriate for combined PR and PS if the
area of stenosis can be dilated to >16 mm.
4.Conduit stenosis
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45. Contraindications
• 22F access is required
• RVOT,Homograft,MPA stenosis <16 mm diameter that is not
dilatable.
• RVOT-MPA diameter >22mm
• Coronary compression on stent implantation.
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46. Valves
• Only commercial available valved stent designed for the
pulmonary position is a jugular venous valve
(Contegra,Medtronic,Minneapolis,MN)sewn into a platinum
balloon expandable stent mounted on a dilation balloon preloaded
into a 22F delivery system (Melody Transcatheter Pulmonary
Valve,Medtronic,Minneapolis,MN)
• Valve diameters range from 16 -22mm.
• Self expanding stents ?
• Edwards SAPIEN valve
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47. Melody Valve
• The Melody valve was approved by the US Food and Drug
Administration (FDA) in January, 2010 for percutaneous valve
replacement under the Humanitarian Device Exemption (HDE)
program.
• The Melody valve is made from a bovine jugular vein valve that is
sewn into a platinum iridium stent and preserved in a proprietary
sterilant of glutaraldehyde and alcohol.
• The Melody valve comes in one size (18 mm diameter; length, 28
mm) that is crimped to 6 mm and re-expanded up to 22 mm. Its
leaflets are very compliant and flexible.
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49. Experience with Melody Valve
• Bonhoeffer’s valve design was eventually acquired by Medtronic and
renamed the Melody Valve (Medtronic Inc., Minneapolis, MN, USA)
and implantation was evaluated in further clinical reports .
• The conclusions from these reports were that
• (a) the procedure is safe,
• (b) the procedure is effective in eliminating PR and reducing the
indexed right ventricular volumes, and
• (c) there is an improvement in the New York Heart Association
(NYHA) functional class during a mean follow-up of 10 months .
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50. Delivery system
• The Medtronic Ensemble delivery system (Medronic Inc.,
Minneapolis, MN, USA), comprises a delivery sheath with a
balloon in balloon (BiB) catheter (NuMED Inc., Hopkinton,
NY, USA) onto which the valve is front-loaded and crimped.
The polytetrafluoroethylene (PTFE) sheath, which covers the
valve during delivery is withdrawn just prior to deployment.
Three sizes of the outer balloon are available: 18, 20, and 22
mm.
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51. Stent design
• Bovine jugular venous valve – upto size 22mm.
• Edwards SAPIEN valve – 23 -26mm.
• 20 -29mm diameter valves are being developed.
• Lower incidence of stent fractures in the stainless steel frame
• Balloon expandable nature – cannot be retrieved once
deployed.
• Unsuitable for transannular patches as some degree of
obstruction required for anchorage.
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55. Recommendations
• The 2010 American Heart Association statement on the Indications
for Cardiac Catheterization and Intervention in Pediatric Cardiac
Disease was expanded to include a class 2a indication for tPVR .
• The recommendation was: ‘It is reasonable to consider percutaneous
pulmonary valve replacement in a patient with an RV-to-pulmonary
artery conduit with associated moderate to severe pulmonary
regurgitation or stenosis provided the patient meets
inclusion/exclusion criteria for the available valve (level of evidence:
B).’
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56. Preprocedural evaluation
• Complete physical examination
• 12 lead ECG
• 2D ECHO
• Cardiac MRI with MRA
• CT angiogram
• CBP,ESR
• Blood grouping typing
• Exercise stress test
• ACT> 250 sec during procedure
• IV antibiotic
• IV fentanyl – for acute pain due to RVOT –MPA stretch.
Assosciated TR
RVH
RV pressure
Conduction delay
Quantify PR
RV.LV SIZE
RV,LV function
Anatomy of RVOT
Anatomy of MPA
Distal branch pulmonary artery stneosis
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57. Procedure
• Under general anaesthesia
• Invasive blood pressure monitoring
• Heparin - at the beginning of the procedure,every hour
thereafter to maintain an ACT>250sec.
• Right heart catheterization – pressures, saturations.
• RV,Pulmonary artery,Aorta,branch pulmonary arteries
• A Stiff guidewire 0.035 Amplatz Ultrastiff Guidewire – placed in
distal branch pulmonary artery – anchor to advance the delivery
system.
• Biplane angiography by Multitrack catheter – tip placed beyond the
pulmonary valve - site for device implantation and quantification
of PR.
• Aortic root angiography – to see whether coronary artery is at risk of
compression – use of 18-20mm Mullins balloon inflated in the conduit
with simultaneous coronary angiography.
• If there is coronary compression – patient to be referred to surgery.
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58. Measure
• RVOT
• Pulmonary valve annulus
• MPA diameter
• Distance from the annulus to the branch pulmonary arteries
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59. Assessment for suitability procedure
• Conduit predilation – balloon size 2 mm larger than the narrowest
diameter of the conduit,less than 110% of the conduit diameter (PTS
sizing balloon,NuMed Inc.,Hopkinton,NY).
• Balloon waist measuring between 14-20 mm at low pressure (< 8atm)
– conduit is anatomically suitable for the procedure.
• Avoid risk of conduit rupture – balloon size to be less than 110% of
the nominal diameter (original size of the implant conduit).
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60. Preparation of the valve
• Three sequential saline baths(5 minutes in each) – wash off the
glutarledhyde in which it is stored.
• Crimping of the valved stent on mandrels of increasing small
sizes prior to front loading onto the delivery system.
• Blue stitching on the distal portion of the device is matched to
the blue portion of the delivery system.
• Retraction of the sheath over the device with simultaneous saline
flush by syringe via the side port to exclude any air bubbles
from the system.
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61. • Femoral vein is dilated to 24Fr
• Delivery system advanced into the RVOT
• Retraction of the sheath from the valved stent
• Contrast injection for confirmation of the position
• Partial deployment by hand inflation of inner balloon.
• Final deployment by outer balloon inflation.
• Deflation of the balloons and the delivery system is withdrawn.
• Post dilation of the valve –discretion of the operator.
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63. Modification of the technique
• Predilation and bare stenting of the conduit
• Looping of the system within the right atrium
• Partial retraction of the sheath.
• Repositioning of the guidewire in the contralateral branch
pulmonary artery.
• Post dilation of the device – no damage to valve leaflets or
affect valve competency.
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64. Other approaches
• Left femoral
• Right and left internal jugular
• Left subclavian vein
• Transhepatic (not advised)
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65. Challenges in procedure
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66. Crossing the RVOT
• If stenotic and tortuous,crossing the RVOT can be challenging.
• If from IVC – looping of the balloon wedge catheter along the
right lateral wall of the RA –TV – tip is displaced towards a
medially displaced RVOT making it easier to cross the
directional wire.
• SVC approach - easier
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67. Compression on proximal organs
• Left main or proximal right coronary artery can be close to
pulmonary annulus
• Patients with homograft or conduit being compressed by
sternum
• Patients with transposed great vessels.
• Preprocedural assessment is important.
• Simultaneous selective coronary angiography during balloon
dilation of the RVOT is required.
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68. Results
• Procedural :
London and Paris United States
No. of patients 155 136
Year 2000 -2007 2007-2009
Mean procedural time 174 ± 67 minutes
Fluoroscopy time 46± 25 minutes
Not performed <10% <10%
Unfavorable RVOT
Coronary compression
Other procedures done in
same sitting
VSD closure,
Paravalvular leak closure,
Coarctation stenting
Bare stenting of the
pulmonary artery,branches
Closure of the ASD
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69. Hemodynamics
London and Paris United States
Post procedure
Regurgitation
Mild Mild
RVOT gradient and RV
Pressures
Fell better in stenosis
than in regurgitation
Fell better in stenosis
than in regurgitation
Increased PADP Increased PADP
Systemic pressures Increased Increased
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70. Complications
London and Paris United States
Major complications 7 8
Instability of the device 2
Homograft rupture 3
Compression of the left coronary artery 1
Compression of the RCA 1
Coronary artery dissection
Conduit rupture
Broad complex tachycardia
Femoral vein thrombosis
Damage to branch pulmonary
artery by guidewire
2 2
Damage to the tricuspid valve 2
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71. Follow up and consequences
London and Paris United States
Median follow up 28.4 months 99 pts – 1 yr follow up
24 – 2yr evaluation
Increased exercise
capacity
More in PR > conduit
stenosis
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72. Hammock effect
• Venous segment of the bovine valve was sutured to the stent only
at its distal extremities.
• Increased incidence of in stent restenosis.
• Seen only in early cohort.
• Can be still seen in the context of stent or suture rupture –
adherence of the venous valve to the stent becomes disrupted –
passage of blood between the wall of the vein and the recipient
outflow tract –stenosis.
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73. Stent fractures
• Multifactorial
• Nature of the stent ,characteristics of the implantation site.
• Bare stenting – 43% ,embolization in 11%.
• Stent fracture following TPVI – 21.1%,stent fracture free survival at 1
year of 85.1% and at 3 years of 69.2%.
• Implantation into a native RVOT
• Absence of RVOT calcification
• Qualitative recoil of the valved stent just after implantation.
Type I fracture Minor ;no loss of stent
integrity
conservative
Type II fracture Major; loss of integrity,
Restenosis on
echocardiography
Repeat TPVI
Surgery
Type III fracture Major; separation of
fragments or
embolization
Surgery
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74. • Hemolysis
• Endocarditis
• Thromboembolism
• Treatment of device related complications :
• Bare stenting – stent in stent technique
• Hammock effect – repeat TPVI
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75. • Valve dysfunction is greater with a primary indication for
obstruction or a mixed lesion as opposed to pulmonary
regurgitation.
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76. Comparison with surgery
• Not feasible
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77. COMPASSION trial
• COngenital Multicenter trial of Pulmonic valve regurgitation
Studying the SAPIEN IntervenrIONal trans catheter heart
valve
• Early feasibility data – encouraging
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78. Hybrid procedures
• RVOT banding via a left thoracotomy with subsequent valve
implantation.
• Shelhigh Injectable Stented Pulmonic valve
• Porcine pulmonic valve mounted inside a self expandable stent
and covered by No React treated perciardium.
• 17-29 mm sizes
• Median sternotomy – trocar that is introduced through small
incision in distal RVOT.
• Transmural sutures proximally and distally.
• Avoid CP bypass.
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79. Rethinking the substrate
• < 5yrs
• <20 kgs weight
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80. Future directions
• Small intestinal submucosa – low profile biodegradable
pulmonary valves.
• Decellularized matrix
• Less immunological rejection.
• Tissue engineering.
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81. Experience with Melody valve
• Freedom from surgical explantation was 83% at 12 months follow up
with no mortality reported.
• Following further clinical experience of tPVR using the Melody valve,
Lurz et al. reported the freedom from transcatheter reintervention as
follows:
• It was also noted that patients with a residual gradient >25 mmHg
were associated with a higher risk of reintervention.
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Freedom from
reintervention
Months of follow up
95% 10
87% 30
73% 50
73% 70

82. US Melody valve trial
• Recently, a multicenter US clinical trial showed freedom from
Melody valve dysfunction or reintervention was almost 95.4%
at 1-year follow-up with a high rate of procedural success
(124/136), and improvement in NYHA functional class
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83. FDAapproval
• November 2010
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84. Take home message
• TPVI technique and valve design offers patients the
oppurtunity of less invasive intervention/reintervention and
may lead to less morbidity and faster recovery.
• The use of Edwards SAPIEN valve in pulmonary position and
successful outcomes make way for the broad scope of
intervention at this valve.
• The trials in pipeline are awaited for further evidence of this
innovative technology.
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