TRANSCATHETER REPLACEMENT OF THE...
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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.
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
70000 worldwide
Conduit failure
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
Available pulmonary valves
Melody® valve
Edwards – Sapien THV
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.
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
BONHOEFER ET AL 2000
12-Year-old boy with stenosis
and insufficiency of a RV-PA
conduit
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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.
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
RESULTS(Melody valve implanters: MS Vienna 2015) *
1000 pts-FU 2006-2013(694:1Y FU)
RVOT obstruction: 40%
PR: 20%
Mixed: 30%*= 8000 Pts
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
RESULTS(Melody valve implanters: MSR Vienna 2015) *
No significant residual gradient
PR: p 0.01 (+-++/ 72 months)
RVEDV + RVESV
Exercise capacity
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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
GREEK EXPERIENCE
25 patients
(Stenotic – regurgitant)
Native RVOT: 2 pt
Dysfunctioning aortic homograph: 19 pts
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
Gore-tex® conduit: 1pt
RVOT patch: 1 pt
Magna Ease valve : 1 pt
Hancock conduit: 1 pt
Age 8-31 years
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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%)
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
GREEK EXPERIENCE
Results
PGr: 0 – 25 mm Hg
PR: 0 (23 pts) – Trivial (2pts)
ComplicationsPrestent embolization: 2 pts
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
FOLLOW-UP
Clinical examination
2-D + Doppler echocardiography
ECG – Holter monitoring
Chest x-ray
Cardiac MRI (MSCT)
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
EDWARDS – SAPIEN VALVE
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
EDWARDS – SAPIEN VALVE
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
Melody ® transcatheter pulmonary 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!!
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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.
TRANSCATHETER TRICUSPID VALVE IN VALVE IMPLANTATION
Godart et al TTVI : A multicenter French studyArchives of Cardiovascular Disease 2014
ComplicationsEmbolizationEndocarditis
CAVBValve failure
Death
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
COMPLICATIONS(Melody valve-Bonhoeffer: PICS 2008)
RPA obstruction: 1pt
CA compression: 1pt
Guide wire perforation: 1pt
GREEK EXPERIENCE
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
Stent fractures=7%
Endocarditis=3%
Conduit tears=5%
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
PATIENT POPULATION
Pulmonary stenosis
TOF + PA
Truncus arteriosus
TOF physiologyTGADORV
70000 worldwide
Conduit failure
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
PRE-CATHETER ASSESMENT
History
ECG
Holter monitoring
Echocardiography2/3 D + Doppler
MRICine Flow studies
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
IMPLANTATION TECHIQUE
BIB catheter 22 F delivery
sheath
Diagnostic cardiac cath
Femoral venous approach
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
IMPLANTATION TECHIQUE
Prestenting
Redilation (HPB) – Residual gradient
Balloon inflation in the RVOT(exclude CA compression)
Pulmonary valve-in-valve implantation(Residual stenosis-stent fracture)
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
POST-PROCEDURAL EVALUATION
Hemodynamic evaluation
Biplane cineangiography
2-D + Doppler echocardiography
EDWARDS – SAPIEN VALVE
Implantation technique
Retroflex I delivery system
Previously placement of stentFor accurate positioning
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
18mm Contegra modified-bovine jugular vein with
valve segment
Melody ® transcatheter pulmonary valve
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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
TRANSCATHETER REPLACEMENT OF THE PULMONARY 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
TRANSCATHETER REPLACEMENT OF THE PULMONARY VALVE
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