The document discusses transcatheter aortic valve implantation (TAVI), including its approval and increasing use in Europe and the United States. It provides details on the team approach, devices, procedures, outcomes, and complications of TAVI based on clinical trials such as PARTNER. TAVI is an alternative to surgical aortic valve replacement for high-risk or inoperable patients with severe aortic stenosis.

1. Transcatheter Aortic Valve
Implantation
TAVI : Current Updates
Magdy Mostafa, MD
Professor of Cardio-Thoracic Surgery
Ain-Shams University

2. • Europe in 2007 approved Edwards SAPIEN and CoreValve TAVI
• It is described as a "runaway train“ phenomena in Europe.
• TAVI procedures made up 1.2% of valve procedures in 2007,
but are expected to exceed 30% in the first half of 2011 .
( Cardiology News Digital Network, Dec,2011 )
• TAVI statistics presented during CardioEgypt 2012 showed that
it exceeded 51% in Europe in the last year.
• USA in November 2011: Food and Drug Administration (FDA)
approved TAVI after PARTNER clinical trial study is concluded .

3. March 1, 2012
AATS, STS , ACCF and SCAI representing cardiologists and cardiothoracic
surgeons released initial recommendations for creating and maintaining
transcatheter aortic valve replacement (TAVR) programs.
• Cardiologists and cardiothoracic surgeons are the cornerstone for
establishing a successful program, noting that a program without both
specialties would be fundamentally deficient.
• Heart team concept that is led by the surgeon and interventional
cardiologist. In all TAVR procedures, the interventional cardiologist and surgeon
must both be present during the entire procedure ensuring joint participation and
optimal patient-centered care.
( Tommaso et al., 2012 by the Society for Cardiovascular Angiography and
Interventions, The Journal of Thoracic and Cardiovascular Surgery, The Annals of
Thoracic Surgery, and The Journal of the American College of Cardiology )

4. The Team Approach for TAVI
CARDIOLOGISTS
SURGEONS
Anesthesiologists
Imaging specialists (Echo, CT, MRI)
(EACTS/ESC/EAPCI , Eur Heart J, 2008; 29: 1463-1470,
Eur J Cardiothorac Surg 34 (2008) 1-8)

5. Where to perform TAVI?
For optimal safety and results, a hybrid operating room with sophisticated fixed
imaging is essential. This includes having the facilities to:
1. Perform angiographic imaging,
2. Provide cardiac anesthesia with transesophageal echocardiography ( TEE )
3. Access to all preoperative diagnostic imaging.
4. Having the ability to convert to an open operation with cardiopulmonary bypass.
5. General anesthesia

7. Inclusion Criteria for TAVI After assessment by the “Team”
1. Severe Symptomatic AS (valve area is < 1.0 cm² or < 0.6
cm²/m²) & Pressure gradient > 50 mm Hg with normal cardiac output
2. Life expectancy >1year
3. Contraindication for surgery ,or High Risk for Surgery :
Clinical judgement + EuroScore (logistic) > 20%;
STS Score >10%
4. AND/OR
- Porcelain aorta
- History of thoracic irradiation
- Severe thoracic deformity
- Patent coronary bypass
(Alec Vahanian, 2008)

8. Access For TAVI
• Femoral vein (Antigrade) : it is no longer used
• Femoral artery ( Retrograde )
• Left ventricular apex
• Subclavian / axillary (left)
• Ascending aorta ( NEW)
( Michael Mack, 2010 )

9. TAVI Primary Operator
TF Cardiologist/Surgeon
TA Surgeon
Subclavian Cardiologist (Access Surgeon)
Direct Aortic Surgeon

10. TAVI Approaches
TA
TF
Shorter time
Less invasive Less radiation
Percutaneous Less contrast
Local anesthesia Easier delivery
--- ---
Delivery more difficult More invasive
More stroke? Less skilled operators
Not for all patients Less experience

11. Subclavian Direct Aortic
• Minimally Diseased Vessel • Most Direct Access
• Less Invasive Than TA • Less Invasive Than TA
• Local Anesthesia Possible • Surgeons More Comfortable
• Crosses Arch But Less With Access?
Traumatic ?
• Direct Access To Valve

12. Balloon aortic valvuloplasty is typically performed with a Tyshak balloon. An
angiogram is performed to confirm proper positioning of the balloon, and during a
short period of rapid ventricular pacing, the balloon is inflated.

13. Transcatheter transfemoral retrograde approach. The valve is advanced over a stiff
guidewire into the aortic position in a retrograde manner. It is positioned such that
60% of the valve is on the ventricular side, and 40% of the valve is on the aortic
side of the annulus.

14. Transcatheter transfemoral approach – completion angiogram of the implanted
aortic valve is shown. Note that the contrast filled aortic root and ascending aorta are
clearly seen, along with the take-off of the right and left coronary arteries.

15. The cardiac apex is accessed and a transapical sheath is placed into the left ventricle. The
valve is advanced over a stiff wire in an antegrade manner. It is positioned such that 50%
of the valve lies on the ventricular side, and 50% of the valve lies on the aortic side.

16. A completion angiogram is performed after the transapical deployment of the valve.
The implanted aortic valve is shown. The completion angiogram should not only
confirm that the aortic root, ascending aorta, and the coronary ostia are intact, but
also that the mitral valve apparatus has not been disrupted by the transapical
approach.

17. Contra indications for TAVI
General contra indications
1.Aortic annulus <18mm or >27mm
2. Bicuspid valves
3. Heavy calcification in front of LM
4. LV Thrombus
Specific contraindications for transfemoral approach
Peripheral arteries
1. Diameter < 8 - 9mm
2. Severe tortuosity /calcification
3. Aorto-Femoral by pass
Aorta
1. Aneurysm of abdominal aorta with thrombosis
2. Severe angulation
3. Porcelain aorta
4. Severe atheroma of the arch
Specific contraindications for transapical approach
1.Previous surgery of the LV using a patch
2. Calcified pericardium
3. Severe respiratory disease
4. Non-reachable apex (Alec Vahanian, 2008)

18. Diagnostic Workup for TAVI
.Measurement of Ilio-Femoral diameters by Angio & MS CT
.Measurements of Aortic Annulus diameter by TTE & MS CT
.Study Aortic Calcification distribution by TTE & MS CT
.Plane of Aortic Annulus by MS CT
.Distance Annulus/ Coronary Ostia by MS CT

19. Plane of the Aortic Annulus/ MSCT
Welt F G et al. Circulation 2011;124:2944-2948

20. MSCT :Distance Annulus /Coronary Ostia
Welt F G et al. Circulation 2011;124:2944-2948

21. CT scan of thoracic aorta of patient with calcific aorta
Welt F G et al. Circulation 2011;124:2944-2948
Copyright © American Heart Association

22. Devices
Current-: 1st Generation
• Edwards Sapien
• Medtronic Core valve
Future-: 2 nd Generation
• Sadra
• Direct Flow
• St. Jude
• Symetis
• Medtronic Engager (Ventor)
• JenaValve
Michael Mack, Southern Thoracic Surgical Association, 2010

23. (A) Sapien balloon-expandable, stainless steel support structure, bovine pericardial valve;
(B) Core self-expanding, nitinol support structure, porcine pericardial valve.

24. Source
Clinical images provided by the American College of Cardiology Foundation ( 2008 )

25. Future Devices
Direct Flow Aortic Valve Sadra HLT Valve
Medtronic/Ventor Symetis ACURATE™ Device JenaClip stent

26. Differences between the Medtronic CoreValve and Edwards Sapien valve systems
Medtronic CoreValve Edwards Sapien valve
Minimum femoral artery 6.5 mm 7 mm
diameter required
Composition Porcine pericardial with Bovine pericardial with steel
nitinol stent stent
Delivery system size required 18 French 18 French (Sapien XT only)*
22 French (23 mm valve)
24 French (26 mm valve)
Native annulus size feasible for 19 mm to 27 mm 17 mm to 25 mm
implant
Mechanism of implantation Self-expanding Balloon expandable
Ventricular rhythm at time of Beating heart Rapid ventricular pacing
implant

27. Possible Complications post TAVI:
1. Stroke:
A. EARLY:
Immediate ( 1st 24 hours ) post-procedural Thromboembolic risk may be due to:
• Periprocedural hypotension.
• Embolism of debris during valve implantation.
• Thrombi can form on devices/ wires during the procedure.
Newer devices that deflect or filter emboli are also currently being investigated.
.
(Tay et al.,JACC, Dec, 2011)

28. B. Delayed
Persists up to the first 2 months after TAVI.
The bioprosthesis itself may be a source of thromboemboli before
endothelialization of the prosthesis is complete :
1. Aggregation of platelet and fibrin on valve leaflet within a few hours after
implantation.
2. The native valve leaflets, may be fissured or denuded are left compressed
adjacent to the stent frame, which again has thrombogenic consequences.
3. Incomplete Endothelialization of stent struts.
(Tay et al.,JACC, Dec, 2011)

29. Pathological Images Showing
Incomplete Endothelialization
(A) Postmortem of a patient who
died on day 25 from pulseless
ventricular tachycardia.
(B) Postmortem of a patient who
died on day 28 after implantation
from stroke-related complications.
Several stent struts are not
endothelialized (black arrow) in this
patient. Areas with tissue ingrowth
(white arrow) are also shown for
comparison.
(Tay et al.,JACC, Dec, 2011)

30. 2. Paravalvular leak:
• Post TAVI moderate to major paravalvular leak varies between (4%–35%)
• It results from inaccurate sizing of the native Aortic annulus.
• This is partly due to intrinsic anatomic properties of the aortic root—the
‘virtual ring’ is largely inhomogeneous, coursing through the muscular
septum, the membranous septum and the mitro-aortic curtain.
( Cerillo et al., 2012 )

31. 3. New-onset AF after TAVI:
• NOAF occurred in about one-third of the patients with no prior
history of AF undergoing TAVI
• The 2 factors associated with the new-onset AF after TAVI :
1. Left atrial enlargement
2. Use of the transapical approach.
• NOAF was associated with a higher rate of stroke/systemic
embolism, but not a higher mortality, at 30 days and at 1-year
follow-up.
( Amat - Santos et al., JACC, Dec. 2011 & Lung et al., JACC, 2012 )

32. 4. Atrioventricular block:
Complete atrioventricular block requiring pacemaker implantation at ≤30 days
was low (1.8% for the TF and 3.8% for TA approach), and it depends on the
depth and level of placement of the valve at the left ventricular outflow track.
(Lung et al., JACC, 2012 )

33. 5. Other major adverse events:
• Major ventricular tachyarrhythmia (0%–4%)
• Myocardial infarction (0%–15%)
• Cardiac tamponade (2%–10%),
• Conversion to surgery (0%–8%),
• Vascular complication (8%–17%),
• Valve-in-valve procedure (2%–12%),
• Aortic dissection/perforation (0%–4%).
(Yan et al., J Thorac Cardiovasc Surg 2010 )

34. Post TAVI Anticoagulation management
• Dual antiplatelet therapy (DAPT) with clopidogrel and aspirin
for 3 to 6 months is a widely accepted strategy in (TAVI) patients
but this approach is not evidence based.
( Lung et al., JACC Vol. 59, No. 2, 2012)
• While the strategy of adding clopidogrel to aspirin for 3
months after TAVI was not found to be superior to aspirin alone.
( Ussia et al, American J. of Cardiology, 2011)

35. Placement of AoRTic TraNscathetER Valve
(PARTNER) clinical trial Study
• This represents the first US 1: 1 randomized percutaneous aortic valve trial.
• A total of 1058 Patient included in 2 Parallel cohort studies individually
powered :
cohort A compared surgical aortic valve replacement versus transcatheter aortic
valve implantation (TAVI) among high-risk operative candidates ( 700 Patient )
cohort B examined outcomes in inoperable patients. ( 358 Patient )

36. One year follow-up of the multi-centre US PARTNER transcatheter heart
valve study
I. PARTNER cohort A :
Included 700 elderly patients (median age 84.1) with severe aortic stenosis
and a mean STS score of 11.8/logistic EuroSCORE 29.3 were randomized to either:
TAVI or Conventional surgery at one of 25 centers.
• 245 patients receiving the experimental device via transfemoral route
• 105 via a transapical procedure
• 350 conventional surgery
Patients in the transapical group were slightly higher risk than patients in
either the transfemoral-TAVI group or the aortic-valve-surgery group.

37. American College of Cardiology (ACC) 2011
US PARTNER cohort A
TAVI vs surgery outcomes:
End point TAVI Surgery p
End point TAVI Surgery p
Mortality
Mortality
30 d 3.4 6.5 0.07
30 d 3.4 6.5 0.07
1y 24.2 26.8 0.44
1y 24.2 26.8 0.44
Major stroke
Major stroke
30 d 3.8 2.1 0.20
30 y
1d 5.1 3.8 2.4 2.1
0.07 0.20
1Major vascular
y 11.0 5.1 3.2 2.4
<0.001 0.07
complications, 30 d
Major vascular 11.0 3.2 <0.001
complications, 309.3
Major bleeding d 19.5 <0.001
Major bleeding
New-onset AF 8.6 9.3 16.0 19.5
0.006 <0.001
Moderate/severe
New-onset AF 8.6 16.0 0.006
PR
Moderate/severe PR
30 d 12.2 0.9 <0.001
30 y
1d 6.8 12.2 1.9 0.9
<0.001 <0.001
1y 6.8 1.9 <0.001

38. One year follow-up of the multi-centre US PARTNER
transcatheter heart valve study
II . PARTNER cohort B :
It enrolled 358 patients with severe aortic disease unable to undergo
surgery at one of 21 centers and randomized them to either:
• Transcatheter valve implantation (Transfemoral, Sapien Valve)
or
• Best medical care, including balloon valvuloplasty.

39. TAVI vs standard therapy at one year: Primary end points
End point TAVI Standard (%) p
(%)
1-y all-cause death 30.7 50.7 <0.001
1-y all-cause death or 42.5 71.6 <0.001
repeat hospitalization
( Leon MB et al. N Engl J Med 2010 )

40. TAVI vs standard therapy secondary end points
End point TAVI (%) Standard (%) p
30-d major stroke 5.0 1.1 0.06
30-d vascular complications 16.2 1.1 <0.001
1-y cardiac death 19.6 41.9 <0.001
1-y major bleeding 22.3 11.2 0.007
Survivors: Cardiac symptoms at 1 y 25.2 58.0 <0.001
( Leon MB et al. N Engl J Med 2010 )

41. One year follow-up of the multi-centre European PARTNER transcatheter
heart valve study
Procedural outcome.
Lefèvre T et al. Eur Heart J 2011;32:148-157

42. One year follow-up of the multi-centre European PARTNER transcatheter
heart valve study
(A) Overall survival for transapical patients.
(B) Overall survival for transfemoral patients
Lefèvre T et al. Eur Heart J 2011;32:148-157

43. Why TA results may not be as good as TF !
• Higher risk patients in TA
* TF First programs bias against TA
• Procedure “less mature”
* Surgeons with lesser “wire skills”
* TA started later and there still is less experience with TA
• More invasive procedure, especially in high-risk patients
Michael Mack, Southern Thoracic Surgical Association, 2010

44. Transaortic Transcatheter Aortic Valve
Implantation

45. European Multi-Center Experience
Out of 1236 patients underwent TAVI using the
Edwards SAPIEN valve, 158 patients (12.8%) the
transaortic approach was used
Transaortic approach results :
• No postoperative strokes
• 30-day all-cause mortality rate of 7%
• Major bleeding rate of 1.3%.
(Bapat et al.,, STS meeting,2011)

46. "Transcatheter aortic valve replacement with Edwards SAPIEN valve via
transaortic route: European Multi-Center Experience" STS 2011
•Initial protocol was to attempt:
Transfemoral approach > Transapical > Transaortic.
But now:
Transfemoral approach > Transaortic access.
• But why the Transaortic approach was not the first choice, given its excellent
outcomes, low risk of stroke.
It is difficult to "sell" the transaortic approach to patients because it involves a 5-
cm incision in the chest, either via a mini-sternotomy or a mini-thoracotomy, as
opposed to a short incision at the groin.
(Bapat et al.,, STS meeting,2011).

47. Conclusion
• Heart team concept should be adopted in every TAVI
procedure
• Transfemoral access need not be the default approach as
no data exist from randomized clinical trials showing that it is
better than the others .
• ‘Indications are slipping’ which means that operable
patients with moderate or low risk score are getting TAVI
when they should have surgery
• Trans Aortic approach is a good and more safe alternative
to both Transfemoral and Transapical approaches.

48. Thank You