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TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE

(PPVI)

BASIL D. THANOPOULOS MD, PhD

Director Interventional Cardiology of CHD

“Euroclinic”

ATHENS - GREECE

Surgical implantation of valved aortic homografts orheterografts is the initial procedure of choice forpatients with tetralogy of Fallot and severe pulmonarystenosis or atresia. This surgical procedure can beperformed with low mortality and rate of complicationsin experienced centers, but valved conduits have limitedlifespan, less than 10 years. As a result, the majorityof patients with right ventricular outflow tract conduitswill undergo multiple re-operations with increasedcomplexity and surgical risk as a result of conduitstenosis and/or insufficiency, particularly, if the initialsurgery was performed early in life.


70000 worldwide

Conduit failure


RATIONALE

Help to reduce the total number of surgeries over the patient’s lifetime by postponing time to surgery while

restoring pulmonic function

Option to intervene earlier, providing better outcomes for patients while avoiding

surgical complications


Available pulmonary valves

Melody® valve

Edwards – Sapien THV

Melody ® transcatheter pulmonary valve


The percutaneous implantation of pulmonaryvalve in patients with dysfunctioning RV topulmonary artery conduits is considered to bethe most exciting advancement ininterventional pediatric cardiology the last 5years.


BONHOEFER ET AL 2000

12-Year-old boy with stenosis

and insufficiency of a RV-PA

conduit


CONDUIT FAILURE(Stenosis + insufficiency)

Progressive RV dilation can lead to eventual heart failure

Enlarged RV can be arrhythmogenic-AF

RV dysfunction can ultimately lead to LV dysfunction

RV failure can lead to early mortality

Timely intervention can save RV function and regress dilatation


INDICATIONS

A. Patients with stenotic and/or regurgitantprosthetic right ventricular outflow tract (RVOT)conduits with a clinical indication for invasive orsurgical intervention.

1. Doppler gr 40 mm Hg

2. Moderate to Severe PR

3. RVEDV 150-170 ml/m²

4.RV Fractional area 40%

B. Existence of a full RVOT conduit ≥ 16 mm/

22 mm when originally implanted.


RESULTS(Melody valve implanters: MS Vienna 2015) *

1000 pts-FU 2006-2013(694:1Y FU)

RVOT obstruction: 40%

PR: 20%

Mixed: 30%*= 8000 Pts


RESULTS(Melody valve implanters: MSR Vienna 2015) *

No significant residual gradient

PR: p 0.01 (+-++/ 72 months)

RVEDV + RVESV

Exercise capacity


COMPLICATIONS(Melody valve implanters: MSR Vienna 2015)

Mortality

Early: 1 pt Late: 6 pts

Homograft rupture: 3 pts

Dislodgment of the stented valve: 2 pts

Stent fracture: 8-20%-<5%

Bacterial endocarditis: 5% (2.4% AR)

Coronary compression: 2 pts (4.7-6%)

RareP.EdemaPA injury


Stent fracture: 8-20%

Mortality

Early: 1 pt Late: 4 pts

AEPC 2011


PPVI Versus SI/R

GREEK EXPERIENCE

25 patients

(Stenotic – regurgitant)

Native RVOT: 2 pt

Dysfunctioning aortic homograph: 19 pts


Gore-tex® conduit: 1pt

RVOT patch: 1 pt

Magna Ease valve : 1 pt

Hancock conduit: 1 pt

Age 8-31 years


GREEK EXPERIENCE

Surgical history

TGA + PS: 3 pts

Ross procedure: 4 pts

Previous surgical conduit replacements2-3 : 8 pts

TOF + APV: 2 pts

TOF + PA: 16 pts


GREEK EXPERIENCE

RVOT obstruction: 14 pts

Mixed (PR): 9 pts

PR : 2 pts Hemodynamic data

PGr: 40-110 mm Hg PR: + -+++

Dysfunctioning RV12 pts: (EF<50%)


GREEK EXPERIENCE


Greek experience


GREEK EXPERIENCE

Native RVOT-TGA


GREEK EXPERIENCE


EDWARDS – SAPIEN VALVE


HANCOCK VALVE CONDUIT


GREEK EXPERIENCE

Results

PGr: 0 – 25 mm Hg

PR: 0 (23 pts) – Trivial (2pts)

ComplicationsPrestent embolization: 2 pts

GREEK EXPERIENCE

Complications



FOLLOW-UP

Clinical examination

2-D + Doppler echocardiography

ECG – Holter monitoring

Chest x-ray

Cardiac MRI (MSCT)


GREEK EXPERIENCE


GREEK EXPERIENCE

STENTEXPANSION

26 mm 23 mm


22-24F DS



GLOBAL EXPERIENCE:36 PTSKenny et al (JACC 2011)

Results

Success: 31/36 (86%)Dgr=15-20 mmHgNo significant PR

Complications:Embolization: 3 pts

VF: 2 pts

Follow-up: 6 mNo valve failure (1 pt)

No stent fractures



Comparative outcome of the Edwards-Sapien and Melody valve

Faza et al (CCI 2013)

Melody valve (13 pts) ES valve 20 pts)

Men RSG =11.2 mm Hg Men RSG =11.2 mm Hg

Stent migration 1 ptStent migration -

No deaths


Medronic native outflow tract device


Venous-P Valve



CONCLUSIONS I

Transcatheter replacement of pulmonary valve using

the Medronic® pulmonary valve implant is a safe andeffective alternative to open heart surgery for thetreatment of selected patients with dysfunctioningvalve conduits. Close collaboration between CongenitalCardiac Surgery and Cardiology teams are key to long-term success!!


CONCLUSIONS II

RV to PA conduits are currently a great first step topulmonary blood-flow repair.

•The Melody™ in its current design is not intended toreplace the surgically placed conduit – but is insteadintended to extend the life of that conduit and reducethe number of operations over the total lifetime ofpatients . Further research is required to improve theimplantation techniques and outcome of

•percutaneous pulmonary valve replacement therapy andto extend it to all patients with a clinical indication to

•delay or avoid open heart surgery.

TRANSCATHETER REPLACEMENT OF THE TRICUSPID VALVE

CONCLUSIONS II

Transcatheter tricuspid valve in valve implantation

using the Medronic® pulmonary valve or the EdwardsSapien valve implants is a new techique that can beused as an effective alternative to surgical valvereplacemt in selective high risk patients withdisfunctioning biological tricuspid valves.However,further studies are required to document its efficasy,safety and long-term results in a larger patientpopulation.


RESULTS(Melody valve-Bonhoeffer: PICS 2008)

TRANSCATHETER TRICUSPID VALVE IN VALVE IMPLANTATION

Godart et al TTVI : A multicenter French studyArchives of Cardiovascular Disease 2014

ComplicationsEmbolizationEndocarditis

CAVBValve failure

Death



20F DS?Cobalt stent


COMPLICATIONS(Melody valve-Bonhoeffer: PICS 2008)

RPA obstruction: 1pt

CA compression: 1pt

Guide wire perforation: 1pt

GREEK EXPERIENCE


Stent fractures=7%

Endocarditis=3%

Conduit tears=5%


Future


Melody valve


GREEK EXPERIENCE

Gore-Tex® conduit; 1pt


PATIENT POPULATION

Pulmonary stenosis

TOF + PA

Truncus arteriosus

TOF physiologyTGADORV

70000 worldwide

Conduit failure


The lifetime for the Melody® device is 2 years.


PRE-CATHETER ASSESMENT

History

ECG

Holter monitoring

Echocardiography2/3 D + Doppler

MRICine Flow studies


IMPLANTATION TECHIQUE

BIB catheter 22 F delivery

sheath

Diagnostic cardiac cath

Femoral venous approach


IMPLANTATION TECHIQUE

Prestenting

Redilation (HPB) – Residual gradient

Balloon inflation in the RVOT(exclude CA compression)

Pulmonary valve-in-valve implantation(Residual stenosis-stent fracture)


POST-PROCEDURAL EVALUATION

Hemodynamic evaluation

Biplane cineangiography

2-D + Doppler echocardiography


GREEK EXPERIENCE


GREEK EXPERIENCE

Gore-Tex® conduit; 1pt


GREEK EXPERIENCE


Implantation technique

Retroflex I delivery system

Previously placement of stentFor accurate positioning


GREEK EXPERIENCE


18mm Contegra modified-bovine jugular vein with

valve segment


Mounted on a NuMed Platinum Iridium Stent28 mm length, Crimped down to 6mm-re-

expanded 18mm up to 22mm

EnsembleTM Delivery System

SheathBalloons (currently

covered by the sheath)

Catheter

Shaft

Hemostasis

Adaptor Access

Site

Guidewire PortOuter Balloon Hub

Inner Balloon Hub

Stopcock

Balloon

size

Indicator

Tip

Marker – Sheath

Uncovered

Marker – Sheath

Covered

Sheath-Hemostasis Valve



GREEK EXPERIENCE

22 patients

Age: 8 – 31 years

Weight: 18 – 58 Kg

Dysfunctioning aortic homograph: 17 pts(Stenotic – regurgitant)

Native RVOT: 3 pt

Gore-Tex® conduit: 1pt

RVOT patch : 1pt


CONTANDICATIONS

1.Venous anatomy unable to accommodate22 F introducer sheath

2. Implantation in the left heart

3. Unfavorable RVOT for good stent anchorageLarge/Severely stenotic

4. Active infection/endocarditis

5. Pregnancy? 6. Allergy to aspirin or heparin

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