This document provides an overview of trans-catheter aortic valve implantation (TAVI). It discusses the indications for TAVI including symptomatic severe aortic stenosis in high-risk surgical patients. The pre-procedural workup involves imaging to assess anatomy and risk. The procedure involves accessing the femoral or other arteries and deploying a balloon-expandable or self-expanding bioprosthetic valve. Complications include conduction abnormalities, paravalvular regurgitation, and hypotension. Two clinical cases are presented of high-risk patients undergoing TAVI.

1. Cath Conference
Abdelkader Almanfi, MD, MRCP-UK
04/24/2014
Trans-catheter Aortic Valve
Implantation

2. Overview
• Introduction
• Procedure
– Indications & Pre-procedural work up
– Procedure & Hardware
– Post-op care, Complications & Management
• Clinical cases
• Conclusions

3. Introduction
AVR
High risk for
surgery
Complications
30-40% do not undergo Sx
•Advanced age
•LV dysfunction
•Multiple co-morbidities
•Pt. preference
•Physician assessment
“Symptomatic Severe Aortic
Stenosis” Prohibitive risk
Inoperability
•~8% mortality (STS, EuroSCORE)
•~2% Stroke
•~11% prolonged ventilation
•Organ failure
•Thromboembolic Complications
•Bleeding
•Prosthetic valve DysfunctionJ. Am. Coll. Cardiol. 2012;59;1200-1254

4. Introduction
Alternatives
• Balloon Aortic Valvuloplasty
– Palliation
– Bridge to AVR
• Medical conservative management  poor prognosis
• TAVI - (TAVI) was developed to address this unmet
need, After the demonstration of feasibility of TAVI in
2002. now widely practiced, with >50 000 patients
treated worldwide, and the technique has been
recommended as an alternative strategy for patients in
high-risk surgical groups.

6. Transcatheter Aortic Valve
Intervention
Indications & Pre-procedural work up

7. Indications
. Symptomatic severe calcific Aortic Stenosis [trileaflet]
who have aortic and vascular anatomy suitable for TAVR
and a predicted survival >12 months, and who have a
prohibitive surgical risk as defined by an estimated 50% or
greater risk of mortality or irreversible morbidity at 30 days
or other factors such as frailty, prior radiation therapy,
porcelain aorta, and severe hepatic or pulmonary disease.
• TAVR is a reasonable alternative to surgical AVR in
patients at high surgical risk (PARTNER Trial Criteria:
STS >8)
J. Am. Coll. Cardiol. 2012;59;1200-1254

8. Indications
Patient selection in clinical trials
Logistic EuroSCORE >20% or STS Score > 10.
J. Am. Coll. Cardiol. 2012;59;1200-1254

9. Contraindications

10. Requisites
• „Heart team‟ approach
– Specific team leader
– Close communication
– „Preplanning procedure‟
• Large cathlabs/ „hybrid‟ rooms
– Fluoroscopic imaging
– TEE capabilities
– General Anesthesia / CPB
– Vascular intervention for vascular complications
– Urgent AVR, CABG,
– Hemodynamic monitoring and management

11. Work up
• Pre-anesthetic work up
• Cardiothoracic evaluation [access, AVR, risk assessment]
• Imaging
– AS severity, morphology, calcification, annular size
and shape
– Aortic root, annulus to coronary ostia distance (>8mm),
Atheroma burden, calcification
– Other valvular disease, sub aortic obstruction
– LV function
– Vascular anatomy from access site to annulus

12. Work up
Role of imaging in pre-procedural and post procedural assessment
J. Am. Coll. Cardiol. 2012;59;1200-1254

13. MDCT imaging for arterial calcification.
Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087
© 2008 European Association for Cardio-thoracic Surgery

14. MDCT imaging for calculation of the dimension of the aortic annulus.
Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087
© 2008 European Association for Cardio-thoracic Surgery

15. MDCT imaging 3D reconstruction of iliac artery.
Maisano F et al. MMCTS 2008;2008:mmcts.2007.003087
© 2008 European Association for Cardio-thoracic Surgery

16. Transcatheter Aortic Valve
Intervention
Procedure & Hardware

17. Procedure & Hardware
• LA + Conscious sedation/ GA, hemodynamic stability [ SBP~120 mm Hg /
MAP >75 mm Hg]
• Vascular access
– Sites
• Transfemoral. Less invasive, can be done LA
• Transapical
– Left ant. Thoracotomy, more invasive
– More direct, shorter catheter, easy delivery
– Septal hypertrophy
– Ascendra2, Sapien valve
• Transaortic
– Upper partial sternotomy
– Mini-sternotomy 2/3 RICS
– Aorta 5 cm above valve
– Less painful, familiar approach to surgeons
– Manipulation of ascending aorta
• Subclavian
Percutaneous
or Cut-down
technique
J. Am. Coll. Cardiol. 2012;59;1200-1254
www.edwards.com

18. Procedure & Hardware
• Pacing leads – Trans venous or epicardial
• Anticoagulation
– Large sheaths
– Heparin [ACT>250]
• Intra-procedural TEE
– Guidewire placement
– Valve placement
• Stable position
• No coronary obstruction
• No interference with mitral valve function
• No conduction system impingement
• No overhanging native aortic leaflets
• Avoidance of aortic root complications (rupture & dissection)
– Post deployment assessment [MR, AR]
TEE- Mid esophageal
long axis view

19. Procedure & Hardware
Balloon Aortic Valvotomy
• Prepping and draping  Anesthesia diagnostic arterial
access: C/L FA access with 6F sheath pigtail catheter
for C/L iliofemoral angiography, location of puncture
marked
• Femoral vein access: I/L to diagnostic access with 7F
sheath, for RHC and pacing leads
BAV Valve implantation
MMCTS.2007.003077

20. Procedure & Hardware
• Therapeutic arterial access: Percutaneous puncture/surgical
preparation standard diagnostic J 0.035 Guidewire +18 or 24F
long sheath, heparin
• Valve crossing : AL1 into ascending aorta exchanged with straight
tip 0.035 Guidewire to cross AV AL1 into LV & wire exchanged
with Amplatz extra stiff 0.035, 260 cm length Guidewire
• Balloon aortic valvuloplasty: 20x40 mm balloon Appropriate
angiographic projection in line with the plane of annulus [LAO/Cran ]
(or you can obtain this angle from CT scan images)  midpoint of
balloon at the annular level PACE INFLATE CHECK
DEFLATE stop pacing
MMCTS.2007.003077

21. Procedure & Hardware
„Sapien XT‟ device „CoreValve‟ device
Self expandable
Nitinol frame
Porcine
Pericardial
Tissue
European Heart Journal (2011) 32, 140–147
Cardiol Clin 29 (2011) 211–222
•Superior hemodynamics
•Lower risk for PPM

22. Procedure & Hardware
CrimperDilator set Inflation device
www.edwards.com

23. Valve Preparation Table
Normal saline
Heparinized Saline
Papaverine & KY Gel
Mineral oil
0.035” “J” Wire
Inflation Device
Edwards Rep & Interventional Cardiologist

24. Progressive Arterial Dilation
18,20,22,23,25 & 28 French dilators
25F Outer Diameter Sheath for 23 mm valve

25. Valve Prep

26. Valve Prep & Delivery

27. Balloon aortic valvuloplasty

31. Procedure & Hardware
Pressure tracings before and after TAVI
European Heart Journal (2011) 32, 140–147

32. Procedure & Hardware
„Sapien‟ device
• Balloon
deployment
• Transapical
deployment also
• Leaflets in open
mode, more
chance for AR
„CoreValve‟ device
• Partially repositionable
• Larger annular size
• Higher chance for CHB
„Sapien XT‟ device
• Lesser calcification
[reduction of 98%
calcium binding sites]
• Shorter stent size
• More radial strength
grater durability
• More closed form, less
chance for AR
www.edwards.com
www.medtronic.com

33. Procedure & Hardware
European Heart Journal (2011) 32, 140–147

34. Device success
– Successful vascular access, delivery and deployment
of the device and successful retrieval of the delivery
system
– Correct position of the device in the proper anatomical
location
– Intended performance of the prosthetic heart valve
(AVA >1.2 cm2 and mean AV gradient < 20 mm Hg or
peak velocity < 3 m/s, without moderate or severe
prosthetic valve AR)
– Only 1 valve implanted in the proper anatomical
location
J. Am. Coll. Cardiol. 2012;59;1200-1254

35. Transcatheter Aortic Valve
Intervention
Post-op care, Complications & Mx

36. Post-Operative Care & Monitoring
• Immediate or early extubation, early mobilization
• Adequate analgesia, control postoperative hypertension,
monitor for any bleed
• Monitor vital parameters including fluid balance, renal
status, and AV conduction system.
• Pre-discharge TTE, DAPT
J. Am. Coll. Cardiol. 2012;59;1200-1254

37. Complications & Management
Left main stem compromise with semi-occlusive displacement
of calcified nodule from aortic valve.
Treated with CPB device explantation  AVR
Also PCI/CABG Cardiol Clin 29 (2011) 211–222
J. Am. Coll. Cardiol. 2012;59;1200-1254

38. Complications & Management
• 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
J. Am. Coll. Cardiol. 2012;59;1200-1254

39. Case # 1
• DB is a 87 year old Male with
symptomatic severe AS
• Ischemic CMP NYHA 4
• BSA 1.83
• Cr 1.09 Hb 14.5
• High Risk due to following
– Frailty
– CAD (CABG)
– PCI (2 months ago)
– ICMP (LVEF 25-30%)
– CHF (Class IV)
– CKD with (B/L renal stents)
39
STS 21.2
Euro Score II 39.02
Procedure Name Isolated AVRepl
Risk of Mortality 21.276%
Morbidity or Mortality 55.053%
Long Length of Stay 35.812%
Short Length of Stay 4.059%
Permanent Stroke 3.397%
Prolonged Ventilation 46.630%
DSW Infection 0.913%
Renal Failure 23.626%
Reoperation 22.903%

40. Echocardiography
• TEE performed
Required Measurements
AVA 0.7 cm2 Peak Velocity 3.17 m/s
AVA index Annulus Diameter 21 mm
Mean Gradient 25 mmHg Ejection Fraction 25-30%
Findings
• aortic valve calcification Severe
• AR Mild
• MR Mild
• TR None
40

41. Echocardiography
22.0 cm
Proposed 26mm
Sapien®

42. Echocardiography

43. Echocardiography

44. CT MIP

45. Vitrea View of Gated CTA of Aortic Annulus
329 mm2

46. CTA :
Small AAA
Aortic bifurcation Proximal common iliacs Bilateral common iliac dissection
Bilateral renal stents Distal Aorta

47. CTA : External iliac arteries

48. CTA : CFA (Axial Views)

49. Procedural Plan
Annulus Diameter
Measurement
THV Valve Size
Proposed
Femoral Access
Side
Proposed
Smallest Vessel
Diameter
Measurement
TEE
24x17 Gated CTA
26 mm TA 7 mm
Special Case Concerns…Reduced EF 25-30%

50. Videos for TAVI procedure

51. Complications & Management
Aortic Regurgitation
•Typically paravalvular mild or
mild-moderate severity
•Most of AR disappears or reduces
at 1 yr follow-up [13% absent, 80%
mild AR]
J. Am. Coll. Cardiol. 2012;59;1200-1254
Cardiol Clin 29 (2011) 211–222

52. Complications & Management
Paravalvular AR
Central valvular AR
Post-deployment balloon dilation, rapid RV
pacing for stabilization, „valve in valve‟
implantation
Usually self-limited, Gentle probing of leaflets
with a soft wire or catheter
Delivery of a 2nd TAVR device, „valve in
valve‟
J. Am. Coll. Cardiol. 2012;59;1200-1254

53. Complications & Management
Rapid Pacing for stabilization
„Valve in Valve‟ Implantation
Reduction
of diastole
Cardiol Clin 29 (2011) 211–222

54. Case # 2
• BH is 80 years old female with
symptomatic severe AS
• NYHA 3 BMI 42.7
• Cr 0.91
• Hb 13.3 PLT 164
• High risk due to following
– CAD-CABG
– DM
– COPD
– Morbid obesity (BMI 42.7)
– CHF
54
STS 16.5
Euro Score II 9.1
Procedure Name Isolated AVRepl
Risk of Mortality 16.524%
Morbidity or Mortality 46.470%
Long Length of Stay 34.552%
Short Length of Stay 5.796%
Permanent Stroke 3.058%
Prolonged Ventilation 43.166%
DSW Infection 1.663%
Renal Failure 24.814%
Reoperation 12.086%

55. Echocardiography
• TEE
Required Measurements
AVA 0.9 cm2 Peak Velocity 3.7 m/s
AVA index Annulus Diameter 21 mm
Mean Gradient 35 mmHg Ejection Fraction 60%
Findings
• aortic valve calcification Moderate
• AR Moderate to severe
• MR Mild to moderate
• TR Mild to moderate
55

56. Echocardiography
22.0 cm
Proposed 23mm
Sapien®

57. Echocardiography

58. Coronary Angiography
Coronary Angiography 11/20/13
Coronary Artery Disease Severe
Prior revascularization (CABG or PCI) CABG
Additional Revascularization Indicated No

59. CT of Aortic Annulus
500 mm2

60. Aortic Annulus
329 mm2

61. CTA :
Distal aorta Aortic bifurcation
Common iliacs

62. CTA : External iliac arteries

63. Peripheral Sizing
• CT Angio
Minimal Luminal Diameters
Right Left
Common Iliac 8 mm Common Iliac 8 mm
External Iliac 7 mm External Iliac 7 mm
Common Femoral 6-7 mm Common Femoral 6-7 mm

64. Procedural Plan
Annulus Diameter
Measurement
THV Valve Size
Proposed
Femoral Access
Side
Proposed
Smallest Vessel
Diameter
Measurement
21 TEE
21x21 Gated CTA
23 mm mm
Special Case Concerns…Access

65. Videos for the TAVI procedure

66. Complications & Management
Causes of hypotension after TAVI
•Vascular complications—iliac rupture
•Ventricular rupture
•Acute valve dysfunction
•Coronary artery obstruction
•Multiple rapid pacing episodes in pts with poor LV function
•„Suicidal‟ LV in severe LVH [After removing AV obstruction LV decompresses to
such an extent that the subvalvular hypertrophy obstructs outflow] treated with
fluids & avoiding diuretics
J. Am. Coll. Cardiol. 2012;59;1200-1254

67. Complications & Management
Significant annular rupture
Ventricular perforation
•Pericardial drainage, auto-transfusion
•Conversion to open surgical closure
Device malposition
Device embolization
Overlapping „valve in valve‟
Urgent endovascular/ surgical
management
Major ischemic stroke
Minor ischemic stroke
Hemorrhagic stroke
Catheter-based, mechanical embolic retrieval
Aspirin, anticoagulants
Anticoagulation reversal, coagulopathy correction
J. Am. Coll. Cardiol. 2012;59;1200-1254

68. Complications & Management
Atrial fibrillation
Rate control/ rhythm control via
pharmacological or electrical
cardioversion
Shock, low cardiac output
Major bleeding
Vascular complications
•Careful systemic pressure management,
inotropic support, IABP, or CPB
•Hemodynamic support, blood transfusion
•Urgent endovascular repair/surgery
J. Am. Coll. Cardiol. 2012;59;1200-1254

69. Case # 3
• RM is 88 years old Male with
severe symptomatic AS
• NYHA 4
• BSA 1.75
• Cr 1.22 Hb 11.5 PLT 181
• High risk due to following
– CAD (CABG x2 & multiple
PCI‟s)
– MR
– CA prostate
69
STS 12
EuroScore II 5.94
Procedure Name Isolated AVRepl
Risk of Mortality 11.994%
Morbidity or Mortality 39.912%
Long Length of Stay 20.333%
Short Length of Stay 8.877%
Permanent Stroke 3.041%
Prolonged Ventilation 32.088%
DSW Infection 0.447%
Renal Failure 12.706%
Reoperation 12.550%

70. Echocardiography
• TEE performed
Required Measurements
AVA 0.7 cm2 Peak Velocity 3.3 m/s
AVA index Annulus Diameter 20 mm
Mean Gradient 30 mmHg Ejection Fraction 45%
Findings
• aortic valve calcification Moderate
• AR Mild
• MR Moderate
• TR Mild
70

71. Echocardiography
22.0 cm
Proposed 26 mm
Sapien®

72. Echocardiography

73. Coronary Angiography
Coronary Angiography 1/29/14
Coronary Artery Disease Severe
Prior revascularization (CABG or PCI) Multiple CABG & PCI‟s
Additional Revascularization Indicated Ostial LAD SVG

74. Coronary Angiography
Ostial SVG to LAD stenosis

75. CT of Aortic Annulus
500 mm2

76. CT 3D
329 mm2

77. CTA :
Distal aorta Aortic bifurcation
Common iliacs

78. CTA : External iliacs

79. CTA : CFA (Axial Views)

80. Peripheral Sizing
• CT Angio
Minimal Luminal Diameters
Right Left
Common Iliac 10 mm Common Iliac 8-9 mm
External Iliac 8 mm External Iliac 8 mm
Common Femoral 8 mm Common Femoral 7 mm

81. Procedural Plan
Annulus Diameter
Measurement
THV Valve Size
Proposed
Femoral Access
Side
Proposed
Smallest Vessel
Diameter
Measurement
20 TEE
Gated CTA
26 mm Right 7 mm
Special Case Concerns…LAD-SVG stenosis

82. Videos for TAVI procedure

83. Conclusion
• Evolving field, may be used in lower risk patients, and
bicuspid AoV
• What is the durability? .. role of TAVI in low-gradient AS?
• Which institutions should be qualified to perform TAVI?
• TAVI for prosthesis degeneration?
• With refinement in procedures and newer improved
hardware may become an attractive alternative to AVR,
repeat procedure possible
• However for Severe symptomatic AS with low risk for
surgery, Surgical AVR remains the standard treatment

84. Thank
You