Review the concept of TAVI Evaluation of patients considered for TAVI Review of evidence Identify future applications

1. TAVI
Dr Vijay Amaranath,DM
NIMS,Hyderabad.

2. Bird’s Eye View
 Review the concept of TAVI
 Evaluation of patients considered for TAVI
 Review of evidence
 Identify future applications

3. Introduction
 Rising life expectancy results in an increase of
degenerative aortic stenosis
 most frequent acquired heart valve disease
and if untreated is associated with high
mortality.

6. Operative Mortality for AVR
 AVR in octogenarians STS2001 UKCSR EHS
• 220 pts (%) 1999-2001 2001
• Op mortality 13% if AVR (%) (%)
• Op mortality 24% if AVR + CABG
AVR
• Morbidity 60% 3.7 3.1 2.7
• Survival 85%, 80%, 73% (1,3,5 yrs)
AVR +
CABG 6.3 7 4.3
 Benefits of AVR in octogenarians
• 81% no/mild disability for daily
activities
• 93% feel less disabled
• 93% reassured to have access to
treatment despite their age
Eur J Cardio Thorac Surg 2007;31:600-606. Eur J Cardio
Thorac Surg 2007;31: 1099-1105. Euro J Cardiothorac Surg
2006; 30: 722-727

7. Many patients are not surgically treated!
Severe AS* - Percent of Patients Treated
J Heart Valve Dis2006;15:312-321; Circulation 2005;
European Heart Journal 2003;24:1231-1243;
Heart 1999;82:143-148

8. Transcatheter Aortic Valve Implantation (TAVI)
• 1993: Andersen
– First description of valve sutured in
stent
– Animal model
– Encountered major limitations
• Obstruction of coronary ostia

9. First human implantation: Alain Cribier
April 16, 2002 ( France)
Bovine pericardium valve
23mm in diameter

10. balloon-expandable valves
 first generation :
Cribier-Edwards valve
 Second generation
Edwards SAPIEN THV
bovine pericardium that
is firmly mounted
within a tubular,
slotted, stainless steel
balloon-expandable
stent

12. ‘Sapien’ device
•
‘Sapien XT’ device
Balloon deployment
• Fewer rows and columns
• Transapical
deployment also • Shorter stent size
• Leaflets in open • More radial strength grater
mode, more chance durability
for AR • More closed form, less
chance for AR

13. CoreValve Revalving device
first implantation in 2005 - Grube et al
• first-generation : bovine pericardial tissue and
was constrained with 25F delivery catheter.
• second-generation : porcine pericardial tissue
within a 21 F catheter .

16. multi-level self-expanding Nitinol frame
• upper third - low radial force : sits prosthesis
in the aortic root
• middle third - high hoop strength ,valve
leaflets are attached ,avoid impinging the
coronaries.
• lower third - high radial force and sits within
the left ventricular outflow tract.

18. Procedure & Hardware

19. Indications
Logistic EuroSCORE >20% or STS Score > 10.
Logistic EuroSCORE >20% or STS Score > 10.

22. Work up
Role of imaging in pre-procedural and post procedural assessment

31. oversizing relative to the aortic annulus
(I)Anchoring to prevent migration
(II) sealing to prevent paravalvular aortic regurgitation
(III)proper valve functioning to prevent patient-prosthesis mismatch

32. Patient Evaluation
• CT Angiogram
– Arterial calcification
– Arterial tortuosity
– Minimal luminal diameter

37. • Vascular access
– Sites
• Transfemoral
• Transapical
– Left ant. thoracotomy
– More direct, shorter catheter
– Septal hypertrophy
– Ascendra2, Sapien valve Percutaneous
Percutaneous
• Transaortic or Cut-down
or Cut-down
– Upper partial sternotomy technique
technique
– Mini-sternotomy 2/3 RICS
– Aorta 5 cm above valve
– Less painful, familiar approach
– Manipulation of ascending aorta
• Subclavian

38. Approaches

39. BAV
• Balloon aortic valvuloplasty: 20x30
mm (for # 23) or 23x30 mm (for #
26)
• Appropriate angiographic projection
in line with the plane of annulus
[LAO200/Cran200]
• midpoint of balloon at the annular
level PACE INFLATE CHECK
DEFLATE stop pacing

41. Transfemoral Approach Sapien Valve
RetroFlex 3 Delivery System
Edwards SAPIEN THV
RetroFlex Balloon Catheter
RetroFlex 3 introducer Sheath Set
Atrion
Inflation Device
Crimper RetroFlex Dilator Kit
41

42. Hardware
Dilator set Inflation device Crimper

43. Hardware

44. Transfemoral Approach
Valve Deployment
RV pacing: 200/min
Aortic
Pressure

45. Edwards SAPIEN implantation

46. Edwards SAPIEN implantation

47. Ascendra™ Transapical Approach
Ascendra™ Introducer Sheath Set
Edwards SAPIEN™ THV
Ascendra™ Delivery System
Atrion Inflation Device
Ascendra™ Valvuloplasy Catheter
Crimper 47

48. Transapical Approach
Direct left
ventricular puncture

49. Transapical Approach
Placement and valve
deployment

50. Transapical Approach

51. three stages of CoreValve deployment.

52. transfemoral approach

53. Subclavian approach

56. closure device such as Prostar XLTM
(Abbott

61. Occlusive iliac dissection

62. Iliac artery rupture…

63. …repaired with a covered stent

64. Transapical Approach
 lung injury,
pneumothorax, or
pleural bleeding
 respiratory compromise
and prolonged
ventilation
 cardiac tamponade

65. Complications & Management
Causes of hypotension after TAVI
••Vascularcomplications—iliac rupture
Vascular complications—iliac rupture
••Ventricularrupture
Ventricular rupture
••Acutevalve dysfunction
Acute valve dysfunction
••Coronaryartery obstruction
Coronary artery obstruction
••Multiplerapid pacing episodes in pts with poor LV function
Multiple rapid pacing episodes in pts with poor LV function
••‘Suicidal’LV in severe LVH [After removing AV obstruction LV
‘Suicidal’ LV in severe LVH [After removing AV obstruction LV
decompresses to such an extent that the subvalvular hypertrophy
decompresses to such an extent that the subvalvular hypertrophy
obstructs outflow] treated with fluids & avoiding diuretics
obstructs outflow] treated with fluids & avoiding diuretics

66. Coronary obstruction
• Displacing an unusually
bulky, calcified native
leaflet over a coronary
ostium
• height of the coronary
ostia, and dimensions of
the sinus of Valsalva.
ostia should be minimally located 14 mm
away from the leaflets insertion.

67. Complications & Management
Left main stem compromise with semi-occlusive displacement of
Left main stem compromise with semi-occlusive displacement of
calcified nodule from aortic valve.
calcified nodule from aortic valve.
Treated with CPB device explantation  AVR
Treated with CPB device explantation  AVR
Also PCI/CABG
Also PCI/CABG

68. (A) Left main coronary artery occlusion resulting from a bulky leaflet displaced over
the ostium. (B) Successful percutaneous intervention restored left coronary
flow.

69. Mitral valve injury
• transvenous, transseptal approach
• antegrade apical approach : avulsion of a mitral
chordae
• ventricular end of a transcatheter prosthesis can be
expected to contact the anterior mitral curtain

70. Complications & Management
Significant annular rupture
Significant annular rupture ••Pericardialdrainage, auto-transfusion
Pericardial drainage, auto-transfusion
Ventricular perforation
Ventricular perforation ••Conversionto open surgical closure
Conversion to open surgical closure
Device malposition
Device malposition Overlapping ‘valve in valve’
Overlapping ‘valve in valve’
Device embolization
Device embolization Urgent endovascular/ surgical
Urgent endovascular/ surgical
management
management
Major ischemic stroke
Major ischemic stroke Catheter-based, mechanical embolic protection
Catheter-based, mechanical embolic protection
Minor ischemic stroke
Minor ischemic stroke Aspirin, anticoagulants
Aspirin, anticoagulants
Hemorrhagic stroke
Hemorrhagic stroke Anticoagulation reversal, coagulopathy correction
Anticoagulation reversal, coagulopathy correction

71. Stroke
• atheroembolism
• Calcific embolism from the aortic valve
• air embolism ; prolonged hypotension, and
dissection of arch vessels

72. Embolic protection device

73. Heart block
• Incidence of CHB requiring permanent pacemaker implantation has been
higher with the CoreValve (19.2% to 42.5%) than with the Sapien valve
(1.8% to 8.5%) [larger profile and extension low into the LVOT
• Occurrence of CHB/LBBB
– BAV 46%
– Balloon/prosthesis positioning &wire-crossing of the aortic valve 25%
– Prosthesis expansion 29%.
• Pre-existing RBBB risk factor for CHB

74. Complications & Management
Aortic Regurgitation
••Typicallyparavalvular mild or
Typically paravalvular mild or
mild-moderate severity
mild-moderate severity
••Mostof AR disappears or reduces
Most of AR disappears or reduces
at 11yr follow-up [13% absent, 80%
at yr follow-up [13% absent, 80%
mild AR]
mild AR]

75. Complications & Management
Paravalvular AR
Paravalvular AR Post-deployment balloon dilation, rapid RV
Post-deployment balloon dilation, rapid RV
pacing for stabilization, ‘valve in valve’
pacing for stabilization, ‘valve in valve’
implantation
implantation
Central valvular AR
Central valvular AR Usually self-limited, Gentle probing of leaflets
Usually self-limited, Gentle probing of leaflets
with aasoft wire or catheter
with soft wire or catheter
Delivery of aa2nd TAVR device, ‘valve in
Delivery of 2nd TAVR device, ‘valve in
valve’
valve’

76. • Acute renal failure - severe renal dysfunction
and dialysis( 3 %) requirement might occur
• Arrhythmia- Atrial fibrillation or ventricular
ectopy might be precipitated by cardiac
manipulation

77. Medications post-TAVI
Aspirin for life and clopidogrel for 3 months
patient on anticoagulation
Warfarin plus clopidogrel for 1 month post-
TAVI, followed by Warfarin plus Aspirin for 1
year and then continue Warfarin only.

87. ONGOING TRIALS

88. PARTNER II Trial: Placement of
AoRTic TraNscathetER Valves Trial
 Edwards SAPIEN XTTM device and
delivery systems: NovaFlex (transfemoral
access) and Ascendra2 (transapical access) in
patients with symptomatic, calcific, severe
aortic stenosis.
 intermediate risk [ STS score of 4-8% ]

89. SURTAVI
• Safety and Efficacy Study of the Medtronic
CoreValve® System in the Treatment of
Severe, Symptomatic Aortic Stenosis in
Intermediate Risk Subjects Who Need Aortic
Valve Replacement (SURTAVI).
intermediate risk [ STS score of 3-8% ]

90. Danish study
 Irrespective of risk score randomized to TAVI
vs SAVR

91. TAVI in Degenerated Bioprostheses
• Aortic
– Capable with CoreValve and Sapien
– Bioprosthesis only
– Annular/Size diameter
• CoreValve: not in annulus < 21mm
• Mitral
– Transapical approach
– Sapien only
• Pulmonary

92. TAVI in a patient with a history of mitral
valve replacement

93. Valve-in-valve
 TAVI in both Stented
and stentless
bioprosthetic valve
dysfunction

94. newly approved transapical
devices

98. • What is the durability?
• What is the role of TAVI in low-gradient AS?
• Which institutions should be qualified to perform TAVI?
• TAVI for prosthesis degeneration?
• Will there be a use of catheter valve implantation in
lower risk population?

99. TAVI is currently the treatment
of choice for patients considered
not to be candidates for SAVR
and proven alternative in high
risk cases .

100. Thank You