Presentation on heart valve devices

1. Percutaneous interventions for
structural heart diseases
Present & Future
Dr. B. K. Iyer

2. The past
 Angioplasty

3. The future - Options for structural
heart diseases
 Primary Method of to date for closure is
surgical
 Recent advances in interventional closure
techniques include Trans-catheter closure
technique
– Eliminates need for cardio-pulmonary bypass
– No need to stop the heart with cardioplegic
agents.
– Implantation of one or more devices via catheter
method

4. Current popular occlusion devices
 Amplatzer Occluder
– (AGA Medical Corporation)
 CardiaStar Septal Occluder
– ( Cardia, Inc.)- extensive European
experience
 Helex Septal Occluder (general
design):
 CardioSEAL Septal Occluder
– (Nitinol Medical Technologies)
 Sideras “Button” device
– (Custom Medical Devices)
 DAS Angel Wings & Guardian Angel
occluders

5. Current popular occlusion devices

6. Current popular occlusion devices

7. Amplatzer Occluder
 AGA Medical corporation, Golden
Valley Mn
 2001- FDA approved for Secundum
lesions
 Nitinol [45% nickel+ 55% titanium]
mesh frame work & separate left /
right atrial disks
 72 nitinol wires woven; micro-welded
ends, super elastic + shape memory
 Success rate:
– 100% surgery, 96 % Amplatzer
 Complication
– 24 % surgery, 7% Amplatzer

8. Amplatzer Occluder
 Filled with fluffy Dacron
fabric patches inside each
disk to promote thrombosis
 Flexible center stem
between disks with microscrew attach / detach
mechanism
 Designed to close
stretched defects 4-38mm
 Completely retrievable
through delivery sheath
– Cost:
– Comparative Surgery cost:

9. Helex Septal Occluder Device
 W.L. Gore & Associates
 Since July 1999
 Nitinol= Nickel+titanium
alloy
 Wire frame in shape of coil
with Gore-Tex
 9 Fr introducer sheath
 Cost:
 Helex defect device
consists of:
– Helex Septal Occluder
Delivery System
components
– Helex Septal Occluder
Device components

10. Helex Septal Occluder Delivery
System components

11. Helex Septal Occluder Device
components

12. Atrial Septal Defect closure

13. Trans-catheter device approach
 Surgery : closure of the defect either by direct
suturing or using a patch .
 Trans catheter device closure: Timing of surgery =
after 1st year & before entry in to school, preferably
in early childhood .
 Device is advanced through an introducer sheath
1.
2.
–
–
Half the device is deployed on left side of atrial septum,
The second half is deployed on the right side
A “sandwich” is formed over the defect
6-8 weeks, device work as a frame for scar tissue to
form. In kids, new tissue formation will continue to grow.

14. Device closure: potential
Complications
 ASD mostly “unsuitable” for device closure
 Air Embolism (via long sheath)
 Device Embolization (transcatheter vs. openheart surgical retrieval)
 Arrhythmias (atrial common; PVCs rare; self
limiting)
 Atrial wall erosion with pericardial tamponade
(rare)

15. Patient Selection
 Strict FDA guidelines
 Follow-up at regular intervals- 3, 6, and 12
months the year following the initial procedure
– Defects smaller than 20-25mm in diameter
– Should not have defects in the very upper or
lower portions of the septum
– Only benefit Ostium Secundum defects
– No lower age limit, but must be more than 8-10 kg
– Ostium Primum or Sinus Venosus, not valid
because defect usually involves heart valves or
abnormal venous drainage from the lungs.

16. Amplatzer device - post implant
 24-48 hrs Fibrin deposits;
– ? trapped thrombus
 1-2 weeks
– Neo-endothelialization begins
 2-4 months
– full neo-endothelium formed

17. Ventricular Septal Defect
closure

18. Conventional Surgical Treatment
vs. others
 Early clinical outcome after surgical repair of
acute ischemic VSD is poor (mortality 30 -50%)
– Cardiogenic shock
– Recurrent VSD
– Complications from prolonged ITU
 Device closure is established as an option for
VSD closure in paediatric patients

19. Technique
1.
2.
3.
4.
5.
6.
7.
8.
9.
General Anaesthesia
Trans-oesophageal echocardiography
Femoral vein/femoral artery
Internal jugular vein/femoral artery
Angiography
+/- Balloon sizing (post-MI only)
Amplatzer device placement and release
Heparin, antibiotics, antiplatelets
Associated procedures (ASD, BAV, RFA, VSD
coil, Pulm Valvuloplasty)

20. Planning & Preparation
1. Maximize fluids and inotropes
2. IABP but shoot coronaries and consider vital
stenting
3. Allow recovery from reperfusion injury
4. Early intervention is usually best
5. Minimize procedural time and trauma
6. Surgical back-up
7. Post-Op care
8. Possible hybrid in some cases

21. Conventional Surgical Treatment
vs. others
 Direct surgical closure of an acute iVSD using
an Amplatzer® muscular VSD device to
1.
2.
3.
4.
5.
6.
7.
Reduce cardiac trauma
Avoid left ventriculotomy
Reduce CPB time
Avoid cardiac arrest
Achieve full revascularisation
Reduce incidence of recurrent VSD
Simplify device deployment

22. Conventional Surgical Treatment
vs. others
 Potential advantages vs. Conventional
surgery
– No incision in the LV
– Reduced CPB time
– No cardiac arrest
 Interventional treatment
– Device deployed under direct vision
– Complete revascularization

23. VSD Closure : CardioSEAL
Device (generic septal occluder)








(NMT Medical Technologies)
FDA approved indication: for
“high risk” Swiss-Chesse
muscular VSD closure
Other uses:
–
–
single congenital muscular VSDs
post myocardial infarction VSDs
Limitations (CardioSEAL):
Non self-centering
Large delivery system (10-11
Fr)
“One chance” deployment with
very limited
retrievability

24. Patent Ductus Arteriosus
Defect closure & coil closure

25. PDA occlusion with an Amplatzer
duct occluder device
 Example of PDA
occlusion with an
Amplatzer duct occluder
device.
 A, Image of an Amplatzer duct occluder
device.
 B through D, Lateral angiograms
demonstrating closure of a PDA with an
Amplatzer duct occluder device.

26. PDA closure with a Nit-Occlud
PDA occlusion device
 Example of PDA closure
with a Nit-Occlud PDA
occlusion device.
 A, Image of a Nit-Occlud coil with its
biconical configuration. Note the
reversed winding on the proximal end.
 B through D, Lateral angiograms
demonstrating closure of a PDA with a
single Nit-Occlud coil.

27. Coil occlusion closure of PDA
 Example of Gianturco
coil occlusion of PDA.
 A, Views of a Gianturco coil in its
stretched out configuration (top) and in
its natural coiled configuration (bottom).
Note the attached Dacron fibers, which
promote thrombosis, along its length.
 B through D, Lateral angiograms
demonstrating closure of a PDA with a
single 0.038-in diameter Gianturco coil.

28. Device closure of ruptured
sinus of Valsalva

29. Surgical closure of ruptured
sinus of Valsalva
 Surgical repair mainstay of treatment in the
past –
– Usually successful (95% survival after 25 years), but
– Recurrence possible (16% reoperation rate)
 Surgical techniques include:
– Primary suture closures (pledget) and patch
closures (if ruptured)
– Aortic root reconstruction or replacement
– Aortic valve repair or replacement

30. Device closure of ruptured
sinus of Valsalva
 Though ruptured sinuses of Valsalva have
been traditionally managed surgically, they
are amenable to transcatheter closure by
using the using the Amplatzer duct occluder
(ADO)

31. Device closure of ruptured
sinus of Valsalva - techniques
1.
2.
3.
4.
5.
General anaesthesia [used in most cases];
TOE guidance is essential
Assess size on TOE and angiogram
Aortogram in LAO &/or RAO projections
Cross defect with Terumo 0.035” exchange guidewire from the
aortic root
6. Snare from right heart and establish AV circuit
7. Usually ADO I of 2-4 mm larger size than the aortic opening of
sinus
8. AGA Torqueview sheath from femoral vein to aorta over guidewire
circuit
9. Deploy device under TOE guidance and assess aortic valve
10. Ensure no increase in AR & encroachment on coronary arteries
prior to release of device

32. Prosthetic Paravalvular leak
device closure

33. Prosthetic Paravalvular leak
device closure
 Rare complication with surgical replacement of
valves and paravalvular regurgitation affects 5-17%
of all surgically implanted prosthetic heart valves.
 Prosthetic Paravalvular leak occurs with mechanical
prostheses [aortic / mitral], bioprostheses or valved
stent
 Patients with paravalvular regurgitation can be
asymptomatic or have hemolysis /heart failure/both.
 Reoperation is associated with increased morbidity
and is not always successful because of underlying
tissue friability, inflammation, or calcification.

34. Prosthetic Paravalvular leak
device closure
 Percutaneous
transcatheter closure
techniques, now
routinely applied in the
management of
pathological cardiac
and vascular
communications are
adapted to PVL
closure.

35. Prosthetic Paravalvular leak
device closure
 Percutaneous transcatheter closures of PVLs using
a wide array of devices have been reported in the
literature, although the procedural success rate of
this approach remains variable
 One major challenge of transcatheter PVL closure
lies in the ability to adequately visualize the area of
interest to facilitate defect crossing and equipment
selection.
 Detecting of paravalvular leaks is done by
1. TTE (Transthoracic Echocardiagraphy)
2. TEE (Transesophageal Echocardiagraphy)
3. ICE (Intracardiac Echocardiagraphy).

36. Prosthetic Paravalvular leak
device closure
 Echocardiographic evaluation of PVL provides
the following information to ascertain
intervention:
–
–
–
–
–
Shape and orientation of the jet
Number of jets
Maximum velocity
Presence of the distal flow reversal
Pulmonary pressures
 The transcatheter approach involves deployment
of occlude devices or coils and adopting either a
percutaneous or a transapical approach.

37. Prosthetic Paravalvular leak
device closure
 Percutaneous approach:
– Access through the femoral vein and transseptal
puncture (mainly for treatment of mitral valve
PVL)
– Retrograde approach through femoral artery
(mainly for treatment of aortic PVL)
 Transapical approach
– involves puncture of the apex either using small
thoracotomy or percutaneous access (direct
puncture).

38. Prosthetic Paravalvular leak
device closure
 After passage of the catheter in the proximity of
the PVL canal, the guidewire is passed across
the canal and the guide is advanced inside.
 Using TEE guidance, the dedicated occluder
(plug) is deployed and the results checked.
– For this procedure either purpose-specific plugs
(Vascular Plug III) or other types of occluders used
commonly for closure of ventricular septal defects or
patent ductus arteriosus can be used.
– Use of coils for narrow PVL canal closure is also
useful.

39. LA Appendage device closure

40. LA Appendage device closure
 The left atrial appendage is a small
pouch, shaped like a windsock, which
empties into the left atrium, one of the top
chambers of the heart
 Atrial fibrillation is a common rhythm
disturbance in which the top chambers of
the heart do not beat regularly.
– When the left atrial appendage does not
squeeze consistently the blood inside the
pouch becomes stagnant and may form clots.

41. LA Appendage device closure
 Once AF develops, patients require
warfarin for the rest of their lives
 Left atrial appendage (LAA) closure is
done in nonvalvular atrial fibrillation (AF)
patients ineligible for warfarin therapy.
 The Watchman device (Boston
Scientific) has been observed to be
noninferior to warfarin therapy in various
studies.

42. LA Appendage device closure

43. [HOCM] Hypertrophic
Cardiomyopathy Obstructive Septal
ablation

44. HOCM Septal ablation
 This is a less invasive method of
↓the outflow obstruction in
hypertrophic cardiomyopathy.
 In this procedure, a few drops of
an alcohol-based solution are
injected into a small branch of the
main artery supplying the
thickened heart muscle.
 This causes part of the muscle to
die (in effect, a small heart attack)
and this in turn reduces the
obstruction to blood flow.

45. HOCM Septal ablation
 Another approach is to use a
procedure, called radio frequency
catheter ablation.
 This is more commonly used to
destroy - or ablate - tissues in the
heart causing rhythm disturbances.
 But research has shown it may also
help children who have HOCM with
thickened heart muscle that obstructs
blood flowing out of their hearts.
 The procedure, performed via
catheters inserted into the groin, has
shown significant improvement

46. MitraClip Mitral valve
percutaneous repair system

47. The MitraClip Mitral Valve Repair
System
 The MitraClip Mitral Valve
Repair System received
approval in Europe over 4 years
ago and is eventually in the U.S.
market since July, 2013
 The MitraClip is intended to
repair diseased mitral valves
without open heart surgery, an
important option for patients not
eligible for such invasive
procedures.

48. The MitraClip Mitral Valve Repair
System
 https://www.youtube.com/watch?
feature=player_embedded&v=GwDgPDYf3
Qo

49. Trancatheter Pulmonary valve
implantation

50. Trancatheter Pulmonary valve
implantation
 Transcatheter pulmonary valve implantation
(TPVI) is an alternative to pulmonary valve
replacement by open surgery.
 It is intended for patients who have
previously had a pulmonary valve repair for
congenital heart disease, in whom
dysfunction of the repaired valve
necessitates further intervention.
 This valve is for designed for use in pediatric
and adult patients with a regurgitant or
stenotic Right Ventricular Outflow Tract
(RVOT) conduit (≥ 16 mm in diameter when
originally implanted).
 This valve is delivered by catheter with
fluoroscopic guidance through the body’s
cardiovascular system.

51. Trancatheter Pulmonary valve
implantation
 The TPV procedure takes 1-2 hours.
 The catheter is inserted into the patient’s
femoral vein through a small access site.
 The catheter holding the valve is placed in
the vein and guided into the patient’s heart.
 Once the valve is in the right position, the
balloons are inflated.
 The valve expands into place and blood will
flow between the patient’s right ventricle and
lungs.
 The catheter is removed. After confirming
with fluoroscopy that the valve is functioning
properly, the access site is closed.

52. Ductal stenting

53. Ductal stenting
 Congenital pulmonary artery (PA) branch
stenosis can occur in isolation, as part of a
syndrome or in conjunction with other cardiac
defects; quite often, PA branch stenosis occurs
after surgical repair of congenital heart disease.
– Significant narrowing of the pulmonary artery origins
can lead an overall reduction in pulmonary blood flow
or to disproportionate distribution to the two lungs.
– In addition, an increase in right ventricular systolic
pressure will result in right ventricular hypertrophy
and possible failure.

54. Ductal stenting
 Ductal stenting is a practical, effective, safer
and minimally invasive procedure to achieve
adequate pulmonary artery growth for
subsequent palliative or corrective surgery.
 Ductal stenting for pulmonary blood supply in
newborns with cyanotic congenital heart
disease (CHD) is a low risk and safe
alternative to the surgical aorto-to-pulmonary
artery (AP) shunt in dual-source lung
perfusion.

55. Pulmonary artery stenting

56. Pulmonary artery stenting
 Pulmonary artery stenoses, mainly
encountered in patients with pulmonary
vasculitis (as in Behçet disease or
Takayasu arteritis), may be treated with
balloon angioplasty and stent placement.

57. Valvuloplasty

58. BMV
BMV (Balloon Mitral
Valvuloplasty)

59. BAV
BAV (Balloon Aortic
Valvuloplasty)

60. BPV
BPV (Balloon Pulmonary
Valvuloplasty)

61. Thank you!