Congenital

1. • Long-term durability of conduits,
bioprosthetic valves, and TAP depends on the
patient age, the cardiac defect,the type of
tissue or material utilized, and the type of the
operation.
• After RVOT correction with TAP, significant
pulmonary regurgitation (PR) is observed in
48% of the patients directly after the
operation and in 85% 2 years later.

2. • In patients after a correction using a valved
homograft, significant RVOT degenerative
dysfunction, PR, and/or pulmonary stenosis (PS)
is observed in 50–55% of the patients during the
first 10 years after the first operation and after 5–
6 years after the second operation leading to
repeat surgical interventions over lifetime . This
can be associated with increased morbidity and
mortality due to chest adhesions, bleeding,
cardiac ischemia, arrhythmia burden, heart
failure, and multi-organ dysfunction

3. • The potential need for repeat surgery in
patient Pulmonary valve replacement makes
transcatheter pulmonic valve replacement
(tPVR) to replace an obstructed and/or
regurgitant pulmonary bioprosthesis or
conduit an attractive option.

4. • RVOT conduit stenting has been shown to
decrease RV pressure and to extend conduit
lifespan However, this treatment option
usually produces free pulmonary
regurgitation, which may be severe as the
leaflets of the previously placed valve/conduit
are rendered incompetent by the stent

5. • Patient management strategies have,
therefore , been based on delaying surgical
interventions for as long as possible, in order
to minimize the number of surgical
procedures. However, delaying surgery carries
a risk of reaching a point of irreversible right
ventricular (RV) dysfunction.

6. • TPVR is feasible and safe when performed in
patients who received pulmonary conduit and or
bioprosthetic valves between the right ventricle
and the pulmonary artery.
• Fewer selected patients post trans-annular patch
repair for tetralogy of Fallot may also be
candidates for this technology. Size restrictions of
the currently available valves limit deployment in
the majority of patients post trans-annular patch
repair. Newer valves and techniques are being
developed that may help such patients.

7. SPVR
• The guidelines focus on significant PR, significant
RVOT obstruction, RV volumetric criteria and
systolic function, occurrence of arrhythmias, QRS
duration, and the presence of hemodynamically
significant residual cardiac defects.
• Symptomatic severe PR and/or PS are class I
indications for PVR in all the guidelines. However,
once symptoms have developed, the RV
deterioration is often irreversible.

14. TTT of PR

15. The ideal anatomy for
tPVR is
• Uniform diameter from RVOT to pulmonary
artery (PA) bifurcation with adequate main PA
length to avoid stenting into the PA bifurcation.
Current indications for tPVR are limited to
dysfunctional surgical RVOT conduits with or
without bioprosthetic valves of more than 16 mm
in diameter.
• However, tPVR has been performed off-label in
patients with native or post TAP repair, and
patients with small sized conduits (< 16 mm) .

16. • Absolute clinical contraindications for tPVR include presence of active
infection and patients with occluded central veins (a hybridm approach may
be performed in such patients). Recurrent IE and active intravenous drug abusers
are also considered contraindications for this procedure

17. • the only two valves that are being used for
tPVR on a large scale include the Melody
valve, as well as the SAPIEN valve

19. Melody Valve
balloon-expandable valve
an 18 mm bovine jugular valve
segment that is sutured onto a
Cheatham platinum (CP) Stent made
of platinum and iridium
The valve functions well over a wide
spectrum of diameters
The valve can be expanded
from 16 to 22 mm in diameter and in
some instances up to 24 mm
Transcatheter Delivery System :m This
consists of a balloon in balloon
(BiB) system which enables the
valve to be repositioned, if needed,
after the inner balloon has been
inflated.
There is a retractable sheath that
covers the stented valve during
delivery and is pulled back just prior to
deployment.

21. Implantation of a Melody® valve. The
positioning of the combined
balloon/stented valve requires a stiff
guide wire and the specialized delivery
apparatus is noted.

22. The SAPIEN XT valve
balloon-expandable
valve
The SAPIEN XT valve consists of three
bovine pericardial leaflets sewn to a
cobalt chromium balloon expandable
stent
The stent has a unique fabric cuff that
covers one half of the frame, limiting
stent expansion. The valve is available in
20, 23, 26, and 29 mm diameters allowing
for implantation in larger RVOT than the
Melody valve. Pre stenting with a
baremetal stent to a diameter 2 to 3 mm
less than the final valve diameter is
performed in most cases, given the
relatively short length of this valve
The ability to shape the sheath
is likely to also assist delivery to RV-PA
conduits via the venous system
The main advantage of this product is
that the valve frame or stent can be
inflated to larger diameters than the
Melody® valve.
Disadvantage may be higher migration
rates related to the shorter length of a
stent which is designed to fixate in a
calcified aortic annulus and avoid
obstruction to coronary blood flow.

23. The vale short arrow is crimped on the shaft of the catheter rather than the balloon
which is marked by two longer arrows

24. The Procedure and
Technical Considerations
-under general anesthesia
-biplane fluoroscopic guidance
-onsite surgical coverage
.- Covered stents should be
available
-Pre-treatment with aspirin and
intravenous antibiotics before valve
implantation
. Heparin
-Right heart catheterization is initially
performed to assess pressures and
saturations with special attention to
any relevant PA branch stenosis.
Use balloon-tipped catheter because
the sheaths and delivery systems used
in this procedure are
relatively large, and if they are
advanced through small chordal
spaces,damage to the TV can occur

25. • If with compliant sizing balloon a significant waist is seen on the
balloon--->increased risk of conduit tear or dissection stent or valve
that needs to be placed in the conduit might need to be implanted
at a smaller diameter or abort the procedure
• During a balloon test dilation aortic root or selective coronary
angiography is done to show the relationship of the expanded
conduit to the coronary arteries (CA compression is not uncommon
with 4.4%). Although non-invasive testing may demonstrate
significant distance between RVOT and CA, all patients should have
simultaneous coronary angiogram with balloon inflation of the
RVOT. If there is any question of potential CA compression, either
from study of the angiograms or electrocardiographic changes,
tPVR is aborted
• SAPIEN valve is usually inflated on a single balloon slowly while
melody BIB is used.

26. • it is important to abolish any residual gradient
before proceeding with tPVR The presence of
residual stenosis has potential deleterious
effect on exercise capacity and valve
degeneration with higher RVOT gradients after
tPVR.

27. • Lifelong low-dose aspirin.
• Mean valve deployment success rate of 95%. Freedom from
re- intervention was 86% over a mean follow-up of 26
months. The most frequent cause for reintervention with
the Melody valve was stent fracture despite pre-stenting
(5–16%).
• NO significant difference in outcome of both types of valves
significant baseline
• TR, often seen in patients with RVOT dysfunction, was
improved in 65% of the patients.
• FC improve
• PR decrease or abolished
• PG decreased

28. pretreatment of
the RVOT with bare metal stent implantation appears
to offer several advantages including
• Creation of a landing zone for valve placement
• maintain a circular configuration of the valve in the long
term
• Elimination of conduit stenoses prior to the valve implant
• Decrease in the incidence of stent/valve fracture that may
lead to early valve failure
If significant recoil is seen after implanting the first stent,
more than one stent need to be implanted
Covered stents, when available, can be alternatively used if
there are concerns of conduit rupture. In some cases, post-
dilatation of the stent using a non-compliant balloon may be
required to achieve the intended diameter.

30. Angio in 34 y male in homograft- narrowing at the junction between RPA and the homograft and severe PR
Selective Left Coronary angio while inflation of the balloon

31. After stenting, The strut leading to LPA was
broken
Angio in MPA after stenting and dilatation
of stent showed severe PR and good
landing zone

32. Final showing good valve position and
trivial PR
Implantation of the Sapien valve

33. • Valve or stent migration with mainly SAPIEN
valve
• Stent fracture with Melody valve

34. • Complications can be divided into the following:
procedural: pulmonary hemorrhage (secondary to
guide wire); ventricular arrhythmias; stent
embolization; coronary artery compression ;conduit
rupture and valve embolization. perforation in distal
PA, femoral vein thrombosis also occur
• Complications at follow-up: stent fracture and
infective endocarditis .
• While these complications were initially reported to be
as high as 12% in early smaller tPVR studies , more
recent trials have shown a decrease of these adverse
events to 5–6%

35. • The rate of serious complications in the US
Melody trial was reported at 6%, including
death from coronary dissection (n = 1),
conduit rupture (n = 1), unstable arrhythmia
(n = 1), wire perforation in distal pulmonary
artery (n = 2), and femoral vein thrombosis(n
=1).
• In the COMPASSION trial ,the rate of serious
complications was 21%

36. Stent fracture
remains an important event with the Melody valve
(5–16%) and remains the most common reason for
re-intervention despite routine pre-stenting. Risk
factors associated with stent fracture include:
• younger age;
• higher pre- and post-procedural RVOT gradient;
• smaller angiographic conduit diameter;
• stent recoil or compression after deployment;
• valve position directly under the sternum

37. • Type I fracture involves disruption of one strut without loss
of stent integrity. These can be seen in up to 40% of the
patients but usually not associated with adverse effect.
• Type II involves fracture with loss of stent integrity,
• type III describes fractures associated with separation of
fragments.
Type II and III are associated with early conduit restenosis and
valve failure.
Follow-up fluoroscopy at regular intervals is recommended
for early detection of stent fracture. A second tPVR, if needed,
can be performed similar to the initial implant.
No stent fracture has not been reported with the SAPIEN
valve.

38. Conduit Rupture
• This complication may occur with either the Melody or
SAPIEN valves.
• Pre and post-deployment balloon dilations have the
potential to cause a tear or rupture in the
homografts/Contegra grafts and conduits.
• Risk factors include
heavy calcification and homograft substrate
The incidence of such complications has been reported to
be as high as 9%, most cases are not associated with
hemodynamic compromise and can be successfully
managed with a covered stent or rarely, surgical conduit
replacement

39. Valve Migration/Embolization
• Valve embolization or migration may require
surgical explanation
• the valve can be deployed in the IVC and
stented
• the Melody valve is entirely covered until
deployed at the target lesion, the valve can be
removed from the femoral vein before
deployment if needed

40. Infective Endocarditis
• 2.4% per patient-year. More than one half of
the cases do not directly involve the
implanted PV, and most respond to antibiotics
without the need for reintervention
• However, infective endocarditis can also lead
to valve explantation, need for a second
procedure, or even sepsis-related mortality

41. Native RVOTs
• previous trans-annular patch (TAP)repair or in dilated native RVOTs. Patch-repaired
pulmonary arteries may be less expandable (dependent on the implanted patch
size) and the stent apposition area may be narrow.
• May be feasible with the SAPIEN valves
• a staged ‘two sessions’ procedure (meaning that the valve delivery is postponed
for one to two months, until fixation of the implanted stents has taken place) may
be an additional option to achieve the best possible results.
• In trans-annular patches showed that good results were achieved by slight
oversizing of the balloon used for stent deployment
• Self-expandable stents may be used for pre stenting , if the RVOT is larger than the
available balloons for stent deployment.
• Post-dilatation of the implanted stents with noncompliant balloons or implantation
of a second or even several stents may help to improve the results. Multiple stent
implantations ( risky) may also be considered to downsize the RVOT diameter and
allow implantation of the largest available valve

42. Future developments
• Aim to reduce the incidence of complications, improve
freedom from re-intervention rates, and, most importantly,
expand the population eligible for this elegant procedure.
• The features of the new valves/devices should include a
lower introducer profile, low inflammatory response, and
long durability, low opening resistance with maximal valve
area, as well as fast and reliable closure and as for all
cardiovascular implants on thrombogenicity.
• Clinical studies in off-label populations, innovative devices,
and new techniques will likely expand the indications to
native RVOTs, small-diameter conduits, and oversized
patched RVOTs.

43. Future Development
• Indications for tPVR are restricted to patients with
RVOT diameter up to 22 mm for the Melody valve and
up to 27 mm for the SAPIEN valve .The majority of
patients [> 80%] who are potential candidates for tPVR
do not fulfill these criteria. For large RVOT (> 26 mm),
RVOT Reducing Techniques are being in development.
One of the techniques reported involving double or
triple metal stent implantation preceding valve
insertion
• there are currently the 29-mm SAPIEN XT and SAPIEN 3
valves available. Both have been recently used
successfully in large native or patched RVOT with
excellent results

44. Self-Expanding Valve Systems
The Venus P
Valve

45. Hybrid Procedure
• Perventricular hybrid implantation through a
subxiphoid approach is an option that should
be considered in very small patients, or
patients with a difficult percutaneous
approach. This hybrid approach has been
successfully used in both the Melody and the
SAPIEN valves. Recently, report on surgical
reduction of the RVOT and transapical
pulmonary valve implantation