05/0

3/20

23PercutaneousPulmonary Valve Interventions

Dr.N.PraveenDM Cardiology Final yr PG

1

05/0

3/20

23

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.

2

05/0

3/20

23

Anatomy of pulmonary valve

3

05/0

3/20

23

4

05/0

3/20

23

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.5

05/0

3/20

23

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.

6

05/0

3/20

23

Percutaneous Balloon Pulmonary ValvuloplastyPBPV

7

05/0

3/20

23

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 8

05/0

3/20

23

9

05/0

3/20

23

• 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).

10

05/0

3/20

23

11

05/0

3/20

23

• 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% . 12

05/0

3/20

23

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

13

05/0

3/20

23

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

14

05/0

3/20

23

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)

15

05/0

3/20

23

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. 16

05/0

3/20

23

17

05/0

3/20

23

18

05/0

3/20

23

19

05/0

3/20

23

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.

20

05/0

3/20

23

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

21

05/0

3/20

23

Cook Rosen 0.035*180 cm curved guide wire

22

05/0

3/20

23

23

05/0

3/20

23

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.

24

05/0

3/20

23

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+) 25

05/0

3/20

23

• 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.

26

05/0

3/20

23

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.

27

05/0

3/20

23

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.

28

05/0

3/20

23

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.29

05/0

3/20

23

30

05/0

3/20

23

31

05/0

3/20

23

Post procedure• As it is a venous procedure complications are less.

32

05/0

3/20

23

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.

33

05/0

3/20

23

SERIES ON PBPV

34

05/0

3/20

23

Stanger seriesValvuloplasty and Angioplasty of Congenital Anomalies 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.

35

05/0

3/20

23

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

36

05/0

3/20

23

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

37

05/0

3/20

23

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)

38

05/0

3/20

23

Cause of restenosis

• Balloon annulus ration <1.2• Gradient post procedure >36 mm Hg

39

05/0

3/20

23

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.

40

05/0

3/20

23

TPVITranscatheter Pulmonary Valve Implantation

41

05/0

3/20

23

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.

42

05/0

3/20

23

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.

43

05/0

3/20

23

Indications 1.Pulmonary Regurgitation2.Failing bioprosthesis• RVOT or MPA diameter < 22 mm in diameter• RV Pressures > 2/3 systemic• RV dilation• Symptoms of exercise intolerance3.Valve implant is appropriate for combined PR and PS if the area of stenosis can be dilated to >16 mm.4.Conduit stenosis

44

05/0

3/20

23

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.

45

05/0

3/20

23

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

46

05/0

3/20

23

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.

47

05/0

3/20

23

48

05/0

3/20

23

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 .

49

05/0

3/20

23

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.

50

05/0

3/20

23

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.

51

05/0

3/20

23

52

05/0

3/20

23

53

05/0

3/20

23

54

05/0

3/20

23

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).’

55

05/0

3/20

23

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 TRRVHRV pressureConduction delay

Quantify PRRV.LV SIZERV,LV functionAnatomy of RVOTAnatomy of MPADistal branch pulmonary artery stneosis

56

05/0

3/20

23

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.

57

05/0

3/20

23

Measure • RVOT• Pulmonary valve annulus• MPA diameter• Distance from the annulus to the branch pulmonary arteries

58

05/0

3/20

23

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).

59

05/0

3/20

23

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.60

05/0

3/20

23

• 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.

61

05/0

3/20

23

62

05/0

3/20

23

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.

63

05/0

3/20

23

Other approaches• Left femoral• Right and left internal jugular• Left subclavian vein• Transhepatic (not advised)

64

05/0

3/20

23

Challenges in procedure

65

05/0

3/20

23

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

66

05/0

3/20

23

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.

67

05/0

3/20

23

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 RVOTCoronary compression

Other procedures done in same sitting

VSD closure,Paravalvular leak closure,Coarctation stenting

Bare stenting of the pulmonary artery,branchesClosure of the ASD

68

05/0

3/20

23

HemodynamicsLondon 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

69

05/0

3/20

23

Complications London and Paris United States

Major complications 7 8

Instability of the device 2Homograft rupture 3Compression of the left coronary artery 1Compression of the RCA 1

Coronary artery dissectionConduit rupture Broad complex tachycardiaFemoral vein thrombosis

Damage to branch pulmonary artery by guidewire

2 2

Damage to the tricuspid valve 2

70

05/0

3/20

23

Follow up and consequencesLondon and Paris United States

Median follow up 28.4 months 99 pts – 1 yr follow up24 – 2yr evaluation

Increased exercise capacity

More in PR > conduit stenosis

71

05/0

3/20

23

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.

72

05/0

3/20

23

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 TPVISurgery

Type III fracture Major; separation of fragments or embolization

Surgery 73

05/0

3/20

23

• Hemolysis • Endocarditis• Thromboembolism

• Treatment of device related complications :• Bare stenting – stent in stent technique• Hammock effect – repeat TPVI

74

05/0

3/20

23

• Valve dysfunction is greater with a primary indication for obstruction or a mixed lesion as opposed to pulmonary regurgitation.

75

05/0

3/20

23

Comparison with surgery

• Not feasible

76

05/0

3/20

23

COMPASSION trial• COngenital Multicenter trial of Pulmonic valve regurgitation

Studying the SAPIEN IntervenrIONal trans catheter heart valve

• Early feasibility data – encouraging

77

05/0

3/20

23

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.

78

05/0

3/20

23

Rethinking the substrate

• < 5yrs • <20 kgs weight

79

05/0

3/20

23

Future directions• Small intestinal submucosa – low profile biodegradable

pulmonary valves.• Decellularized matrix• Less immunological rejection.• Tissue engineering.

80

05/0

3/20

23

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.

81

Freedom from reintervention

Months of follow up

95% 1087% 3073% 5073% 70

05/0

3/20

23

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

82

05/0

3/20

23

FDA approval• November 2010

83

05/0

3/20

23

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.

84

05/0

3/20

23

85

THANK YOU