An extensive presentation on the upcoming catheter based aortic valve implantation including a future perspective of TAVI

1. Transcatheter Aortic Valve Implantation
(TAVI)
Dr. K. Srikanth
DNB (Cardiothoracic Surgery) Resident – 3rd year
Narayana Hrudayalaya, Bangalore
31.12.2019

2. Outline of presentation
• History
• Anatomy (TAVI specific)
• Indications & Contra-indications
• Valve options
• Technique
• Complications
• NH experience
• Future direction

3. Why should you know about TAVI?
• Structural Heart Interventions are coming up in a big way
• Surgeons of the future need to be ‘interventional surgeons’
• In the west, a good number of TAVIs are performed by surgeons, so
you might be performing TAVI one day!
• To deal with the complications of such procedures

4. History of TAVI
• First balloon aortic valvotomy – 1988 by Dr. Alain Cribier
• Recurrence of symptoms due to restenosis in 6-8 months
• 1993 – Alain Cribier demonstrated in cadaveric hearts that a stent
across the aortic valve was well anchored within the aortic annulus,
there was no recoil and the coronary ostia were unobstructed

5. First drawing by Cribier in 1994
conceptualising TAVI

6. First human implantation – 2002
On April 16, 2002, at the Charles Nicolle University
Hospital in Rouen, France, the Interventional
Cardiologist, Professor Alain Cribier performed the
first transcatheter aortic valve implantation
procedure in the world. He used a Percutaneous
Valve Technology (PVT) percutaneous heart valve.

7. • A 57-year old man in cardiogenic shock secondary to severe aortic stenosis
received the transcatheter heart valve on compassionate basis
• Because of hemodynamic instability and multiple co-morbidities, surgeons
refused to operate. Severe peripheral arterial disease forced the team to
implant the valve using an antegrade approach with transvenous and
transseptal puncture
• First-in-human transcatheter aortic valve implantation using a 24Fr
catheter delivery system that housed a 23-mm bovine pericardial stent
valve
• After valve implantation, the transvalvular aortic gradient was less than 10
mmHg and the aortic valve area increased to 1.7 cm2. These excellent
results were never before observed with balloon aortic valvuloplasty.

8. • This patient had a stormy post-procedure period (pulm embolism, sepsis,
limb ischemia) and a satisfactory follow up period with good hemodynamic
& echo parameters until he succumbed to sepsis 17 weeks later secondary
to mid thigh amputation stump infection due to pre-existing PVD
• Thereafter in Rouen on compassionate basis, the first series of 40 patients
underwent implantation of a modified model heart valve, the Cribier-
Edwards valve (equine pericardium), using an antegrade transseptal
approach
• Antegrade transcatheter aortic valve implantation was technically
challenging and caused hemodynamic instability from mitral valve
tethering and injury made the procedure too risky.
• As a result since 2004, retrograde transcatheter aortic valve implantation
via the femoral artery (transfemoral) and apex of the heart (transapical)
proved to be more reproducible and safer

9. Indications of TAVI
- What do the latest international guidelines
recommend?

10. Management
algorithm for Severe
AS – ESC/EACTS (2017)
guidelines

11. ESC/EACTS (2017) TAVR guidelines

12. ESC/ EACTS
(2017)
guidelines
(TAVR vs SAVR)

13. AHA (2017) TAVR guidelines

14. Contraindications to TAVI

15. Anatomy for TAVI

16. • The relationship of the left ventricular outflow tract to the aortic root
differs between elderly and younger patients with a more acute angle
(90-120 degrees) being encountered in the elderly group
• For the purposes of transcatheter aortic valve implantation (TAVI), the
“aortic valve annulus” corresponds to a virtual ring formed by joining
the basal attachment points of the leaflets within the left ventricle
• The aortic valve plane represents the inlet from the left ventricular
outflow tract into the aortic root

17. Pre-procedure investigations
• Transthoracic echocardiography (TTE)
• Transesophageal echocardiography (TEE) – earlier used for TAVI but
underestimated the annulus size causing paravalvular leak (PVL)
• Multi-Slice ECG-gated Computed Tomography (MSCT) - most informative
and gold standard
• Contrast aortography
• Magnetic Resonance Imaging (MRI)

18. What to look for in MDCT?
• Atherosclerotic burden [A]
• Vessel tortuosity or ‘bending’ [B]
• Calcification [C]
• Diameter [D]

19. ‘Skin to valve’
analysis using MDCT
for TAVI planning

20. Access route
decision

22. Coronary ostial height from annular plane Ideal fluoro projection for valve deployment

23. Aortic annulus concept –
Natural aortic annulus is oval
in shape which becomes
circular after deployment of a
valve

24. Aortic annulus
measurement

25. Comprehensive CT analysis for TAVI – Key to a
successful outcome
What are the elements of a TAVI CT study?

27. Valve ‘over’sizing
• In general balloon-expandable prostheses are oversized 10-20%
relative to the aortic annulus This ‘planned’ oversizing helps to anchor
the prosthesis which is sutureless.
• In addition, they assume a circular shape irrespective of the native
annulus, in contrast to self-expanding platforms which ‘mould’ to the
native annulus anatomy.

28. Summary of TAVI decision-making
• Risk criteria (based on STS/ EuroSCORE) – at present, TAVI is
recommended only for high risk patients (both AHA & ESC guidelines)
• Anatomical criteria – as discussed earlier
• Patient criteria - Co-morbidities are frequent in the typical population being
considered for TAVI. A multidisciplinary assessment of the patient in the light of
these factors is essential for the appropriate selection and safe conduct of a TAVI
program
• Heart Team - cardiac surgery, cardiac anaesthesia, interventional and general
cardiologists, imaging specialists (from cardiology and/or radiology), geriatricians and any
other relevant area (e.g. nephrology, neurology)

29. • Fraility index - The appearance of frailty can be perceived by experienced
clinicians. Objectively defining this physiological state, however, remains
challenging. In practice a combination of subjective evaluation and objective
parameters such as the Katz score or Charlson comorbidity index, grip strength
(assessed with a dynamometer), validated walking test and albumin are used.
• Futility index - Patients at extreme risk who have a limited life expectancy
(arbitrarily considered to be <1 year) or who are unlikely to gain any meaningful
symptomatic relief due to significant comorbidity, should not undergo this
procedure due to futility.
• Operator and institutional criteria - Operator learning curves for SAPIEN
from the PARTNER trial suggest an average of 26 cases for transfemoral TAVI and
between 30 and 45 cases for trans-apical TAVI were needed to achieve a plateau
in adverse events

30. TAVI Hardware
• Bioprosthetic valve prosthesis (mechanical valves can’t be used
because of the inability to ‘crimp’ it)
• Delivery catheter
• Loading system
• Deployment mechanisms - self-expansion, balloon expansion and
inflatable platforms
• Ancillary device facilitators – sheaths, guidewires, balloons

31. Balloon Vs self-expandable valves

32. • Sheaths - These have progressively reduced in size from 24-26 Fr (8.0-
8.7mm) to 14-16Fr for balloon-expandable prostheses and 18Fr
(6.0mm) for self-expanding prostheses
• Guidewires - All the wires for TAVI are of exchange length (260cm+)
and consist of a solid proximal core with a distal atraumatic soft tip
(to prevent LV perforation)
• Balloons - These have a length of 4-5cm so as to provide an anchor
and eliminate movement during inflation which is typically performed
at 4-6atm. Newer designs incorporate a waist to enhance anchoring
further.

33. Devices available
• Currently there are 12 percutaneous prosthetic aortic valve systems (8 for
transfemoral use, 4 for trans-apical use) that have Conformité
Européenne (CE) approval and 2 that have Federal Drug Administration
(FDA) approval for use in Europe and the North America respectively.
• There are two generations of TAVI valves as of today - Medtronic
CoreValve, Edwards SAPIEN THV and Edwards SAPIEN XT were considered
early first generation devices, whereas Edwards SAPIEN 3 (Edwards
Lifesciences), LOTUS valve system (Boston Scientific, Natwick,
Massachusetts, USA) and Medtronic Evolut R (Medtronic) were considered
newer second generation devices.
• R3 concept - re-sheathable, re-positionable, and retrievable devices are
considered to be ideal

35. SAPIEN 3 Valve
(Edwards
Lifesciences)
• Bovine pericardium
• Balloon expandable
• Lowest profile
• Dedicated outer skirt
to minimise PVL
• Row of large cells to
allow easier coronary
access
• Approved for femoral
and apical access

36. Medtronic Corevalve
• Self-expanding valve
• Useful for small annuli (18-20mm), 23mm valve can be deployed as it is supra-
annular

37. St. Jude medical Portico valve

40. Jena valveDirect Flow valve
• Balloon-expandable valve
• Out of market
• Trans-femoral and apical routes
• Only CE approved valve for pure AR
as it has nitinol hooks which anchor
to the native leaflets

41. LOTUS Edge valve
• Trans-femoral and trans-aortic routes
• 14 Fr delivery sheath – 2nd generation
• 21mm-29mm valve sizes
• Rapid pacing not required
• Fully repositionable, retrievable

43. Medtronic
Engager
• Only for trans-
apical use

44. Steps of Trans-femoral TAVI

45. Anesthesia
• Increasingly procedures are being performed under local anesthesia
with or without sedation
• General anaesthesia and intubation is thus not mandatory for all
cases and is typically reserved for non-femoral approaches or
anticipated complex femoral procedures
• Currently half of all transcatheter procedures are performed under
general anesthesia worldwide
• Routine pre-procedural antibiotic prophylaxis is administered

46. Contra-lateral access
• The majority of practitioners use a right-sided transfemoral approach
for the TAVI sheath and delivery system with secondary access from
the left femoral artery for a pigtail catheter to be used for supra-aortic
angiography or, vice-versa due to arterial quality and lack of
tortuosity.
• Alternative secondary access from the radial artery is performed by
some practitioners.

47. Puncture
• Heparin is administered to target an ACT of 250-300sec for the procedure
• This should always be image-assisted to ensure the puncture point is in
common femoral artery segment over the femoral head and avoiding the
femoral bifurcation.
• Fluoroscopy and antegrade contrast acquisition from a catheter, typically
an internal mammary catheter, placed at the distal aortic bifurcation is
performed.
• Alternative or supplementary techniques such as digital subtraction
angiography or ultrasound can also be used.

48. Pre-closure
• This can be performed with a variety of dedicated devices such as
ProGlide (Abbott Vascular, Redwood City, CA), Perclose or ProStar
(Abbott Vascular Inc, Santa Clara, CA), all of which can be placed
either as a single device or as a pair to give a cruciform configuration.
• Preclose demo video

49. Sheath insertion
• Insertion of a stiff guidewire allows for insertion of the TAVI delivery
sheath by providing support and straightening any iliofemoral
tortuosity
• For challenging anatomy due to peripheral arterial disease a balloon-
expandable sheath may be necessary

51. Prosthesis preparation
• The majority of prostheses require on-table preparation which
involves crimping the prosthesis onto the delivery system
• Care is required to ensure the prosthesis loaded in the correct
configuration to avoid an inverted valve being deployed in error.
Newer generations of devices may come pre-packaged on delivery
systems.
• Valve crimping video

52. Temporary pacemaker implantation
• Temporary pacing is required for pre-dilation, post-dilation, or prosthesis deployment
under rapid pacing to prevent device ejection by systolic contraction
• In addition, it serves as protection against the potential development of bradyarrhythmia
following TAVI.
• The right internal jugular vein or femoral vein is used typically.
• The temporary pacing wire is retained following the procedure for varying periods of
time with self-expanding valve prostheses
• Rapid pacing has also been used to reduce ventricular tearing and haemorrhage during
sheath removal for trans-apical
• Pacing rates must be high enough to cause a fall in systolic BP and this typically occurs
>160-220bpm.

53. Valve crossing
• The calcified aortic valve can be a challenge to cross. The most frequently used technique
involves probing the aortic valve in a systematic clockwise or anti-clockwise fashion using
a standard straight-tipped wire through an Amplatz catheter in the LAO projection
• Alternative catheters such as an internal mammary or Judkins right (JR) can be used
dependent on the horizontal lie of the aortic root
• A pigtail catheter is placed in the non-coronary sinus of Valsalva and aortic root
angiography is used to determine the position of equipment relative to the coronary
cusps.
• The aortic annular plane (the nadirs of the non, right and left coronary cusp leaflets)
should be perpendicular to the valve device and co-axially aligned. Rotational
angiography to find a projection with all three aortic valve leaflets superimposed equally
helps to ensure optimal deployment precision.

55. Pre-dilation
• Systematic pre-implant dilation to prepare the aortic landing zone for
TAVI is performed in patients with severe calcification.
• If performed this involves right ventricular pacing at rates 160-
180bpm for up to 20 seconds in order to reduce left ventricular stroke
volume and allow several seconds of balloon inflation.
• Importantly the size of the balloon should not exceed the minimum
aortic annulus diameter from the CT scan.

56. Positioning
• Correct implantation depth is a critical feature of a successful implant.
• Accurate placement of the prosthesis requires visualization of both the
aortic annulus plane and that of the device delivery catheter overlap
perpendicularly.
• Co-axiality of the prosthesis/delivery system and the center of the aortic
valve is important. Aortic root-LVOT angulation > 90 or <45 degrees can
make prosthesis deployment uneven.
• Traditionally there are two methods used to determine that the device is
coaxial with the annulus: the line of perpendicularity method and the
centerline method.

57. A more accurate system
has been developed
which can be applied to
all TAVI systems and
involves the use of a
fusion of fluoro and CT to
create a ‘double S curve’.
In essence this is where
the annulus and delivery
system ‘perpendicularity’
curves intersect. This will
frequently be in the RAO
caudal projection as
opposed to the more
traditional LAO cranial
projection

58. Post-valve deployment assessment
• An assessment of the presence of PVL should be made with echo
and/or angiography.
• In addition, the AR index can be calculated ([DBP-LVEDP]/SBPx100,
values <25 imply a good prognosis with a mortality at 1 year of 16.7%
vs 46% for values >25 at 1 year p<0.001)

59. Post-dilation
• Post-dilatation may be needed in about 25% of cases in order to
achieve optimal prosthesis frame expansion and reduce residual PVL.
• It is successful in roughly half of cases is also associated with an
increased risk of peri-procedural stroke. If unsuccessful, a TAV-in-TAV
may need to be performed

60. Haemostasis and vessel closure
• This can be via elective open surgical repair or by fashioning knots
with percutaneous pre-closure suture-based device
• Although these percutaneous devices weren’t originally designed for
TAVI they now have CE approval and are able to close arteriotomies
up to 24Fr in diameter.
• TAVI video

61. Anticoagulation post-TAVI

62. Alternative access sites for TAVI

63. SUBCLAVIAN/TRANSAXILLARY
• This the most frequent non-femoral access point used. Typically performed
via a surgical cut-down when in the subclavian portion. If transaxillary it
can also be performed percutaneously with pre-closure sutures most
frequently into the proximal third of the axillary artery.
• The short distance is an advantage but the acute angulation induced by the
subclavian-aortic junction makes the sheath prone to kinking
• Dissection and bleeding can be challenging to control even with open
surgical access. A left-sided approach is selected in >95% of cases due to
this offering a more favourable alignment of the prosthesis with the native
valve.
• The presence of a patent LIMA graft is considered a relative contra-
indication.

64. TRANS-AORTIC
• A right anterior mini-thoracotomy is used for patients with a right sided
ascending aorta or patent coronary bypass grafts and a mini-J sternotomy for
middle or left-sided ascending aortas and a deep anatomical location or pre-
existing lung disease
• The aorta is inspected to avoid areas of calcification. Using a purse-string suture,
needle puncture and access with a haemostatic sheath is obtained.
• The puncture is made with a minimum of 6cm for CoreValve and 8cm for SAPIEN
platforms. The valve is then deployed in the same way as via the transfemoral
approach
• Compared to the transapical route advantages include faster mobilization and
avoidance of an LV apical scar which can sometimes result in a pseudoaneurysm.
Compared to the axillary route advantages include avoidance of significant
peripheral vascular disease and potential for occlusion of the vertebral and, in
those with CABG, the internal mammary artery. (VIDEO)

65. TRANS-CAROTID
• This is performed under local anaesthesia with cerebral oximetry
monitoring.
• Satisfactory vessel size and vessel quality are critical determinants for
efficacy and safety as is an anatomically complete Circle of Willis.
• The short distance and provision of a direct coaxial approach to the
aortic valve is an advantage.
• Stroke is the main disadvantage.

66. TRANS-APICAL
• This is performed via a left anterolateral thoracotomy followed by needle
puncture of the apex through a pledgeted purse-string suture
• A dedicated haemostatic sheath is applied and the valve deployed in a
similar fashion to the transfemoral approach thereafter.
• The advantages of this route are the short distance to the aortic valve and
antegrade delivery allowing for more precise control, disadvantages
include haemorrhage, tamponade and left ventricular pseudoaneurysm.
• Contra-indications include the presence of left ventricular thrombus and/or
a ventricular aneurysm. Dedicated apical closure devices have been
developed and are beginning to enter clinical use (Video)

67. TRANS-CAVAL
• This percutaneous route has been used in those who lack
conventional access options. It is technically challenging and there is a
significant ‘learning curve’.
• The procedure consists of femoral vein access and puncture across
the inferior vena cava into the abdominal aorta using a coronary
guidewire to apply electrocautery energy and create a caval-aortic
fistula.
• The remaining steps up to deployment are conducted in the
conventional way and then the fistula is closed with a percutaneous
device such as an Amplatz PDA occluder

68. TRANS-SEPTAL
• The original method of access during the pioneering days it involves
femoral venous access , trans-septal puncture and an anterograde
approach to the aortic valve.
• Although of historical interest, due to the potential for entanglement
within the mitral valve apparatus this method has been abandoned.

69. Complications of TAVI
Cardiovascular complications
Non-cardiovascular complications

70. Cardiovascular complications
- Paravalvular Leak (PVL)
• The potential mechanisms for PVL includes heavy calcification,
malpositioning (too low resulting in PVL over the pericardial skirt or too
high leading to PVL by inadequate annulus sealing) , dysfunction of one of
the leaflets, a very ellipitical annulus, a small valve relative to annulus
(referred to as the cover index) and an under-expanded valve
• While first generation prosthetic valves together with a reliance on
echocardiographic sizing of the aortic annulus in the early days was
associated with a broad frequency of at least moderate severity of 10-30%;
nowadays the use of CT imaging and prosthesis designs to improve annular
sealing through conformability and radial force have reduced this to
broadly under 10%

71. • If the mechanism is valve malposition then a second valve-in-valve
procedure is warranted.
• If the leak is due to under-expansion then post-dilatation is
warranted.
• Prevention of paravalvular regurgitation requires the prosthesis to be
conformable, have accurate annular dimensions, and sufficient radial
force. However, sealing occurs at more than just the annulus and
future improvements may be contingent on 3D modelling
programmes that predict the ‘seal’ based on the valve type, individual
aortic root anatomy together with the extent and distribution of
calcium.
• Second generation TAVI valve designs have helped to mitigate against
moderate/severe regurgitation compared to first generation valves

72. Stroke
• The mechanism for this much-feared peri-procedural complication is
embolism (either from atheromatous and calcific material or thrombus
either related to atrial fibrillation or endovascular manipulation during the
procedure)
• Diffusion-weighted brain MRI imaging, particularly with 3-Tesla machines,
detects perfusion deficits in the vast majority of patients undergoing TAVI
whether via the femoral or transapical approach.
• These are not associated with any clinically-measurable neurological deficit
and the long-term meaning of this imaging finding although concerning is
uncertain currently. Nevertheless, cerebral protection devices have also
demonstrated macroscopic debris (consisting of valve tissue, thrombus,
collagenous tissue, and calcium) in the vast majority of procedures.

73. • The challenge thus posed has fuelled the development of cerebral
protection devices that either deflect debris away from the head and
neck vessels or capture material in toto.
• Commercially available devices include Embrella, TriGuard, Embol-X
devices
• Triguard video
• Embrella video

74. Conduction abnormalities
• Atrial fibrillation - one-third of patients with increasing left atrial size and a
transapical approach being independent predictors
• Temporary and permanent conduction abnormalities particularly left
bundle branch block due to the proximity of the LVOT portion of the device
to the left bundle branch
• LBBB alone (i.e. if no permanent pacemaker is implanted) is not associated,
in the majority of observational studies, with procedural mortality
• The frequency of new LBBB after TAVI is 35-35% with CoreValve and 10-
30% with SAPIEN.

75. • Predictors of the need for permanent pacemaker implantation
include pre-existing LBBB and left axis deviation, right bundle branch
block, the thickness of the non-coronary leaflet, depth of device
implantation from the non and left coronary leaflets, and septal
thickness
• The depth of implantation is the only modifiable factor and reducing
the depth of implant to less than 5mm also reduced the incidence of
new conduction abnormalities and pacemaker implantation.
• The permanent pacemaker implantation rate for CoreValve is 13-39%
and 4-10% with SAPIEN.

76. VASCULAR INJURY
• This is related to sheath size and can include arterial dissection,
perforation, failed percutaneous closure, and arterial avulsion. A
meta-analysis of 16 published trials gave a range of 5-23% of vascular
access site complications
• Temporary control of iliofemoral vascular tear or rupture during
sheath insertion or removal may be obtained by temporary balloon
occlusion from the contralateral femoral artery until open surgical
management is perfomed

78. Coronary obstruction/ occlusion
• Coronary obstruction is a critical complication caused by native leaflets and
device skirt overlapping the coronary ostia.
• The heights of the ostia are variable and pre-procedural planning is the key
element in maintaining safe clearance. Obstruction occurs most frequently with
the left coronary and a height of <12mm and/or sinus of Valsalva <30mm.
• It seems to occur particularly if a valve-in-valve procedure is performed
• The left main ostium is the most frequently reported coronary vessel to be
obstructed , and when recognised can be rescued with immediate PCI.
• Importantly, unexplained hypotension (as opposed to ECG signs of ischemia) may
be the only clinical sign.

79. PERICARDIAL EFFUSION AND TAMPONADE
• This complication is due to cardiac chamber or aortic annulus
perforation and most frequently related to temporary pacing wire
perforation of the right ventricle or guidewire or catheter perforation
of the left ventricle, particularly with stiff equipment.
• Most events occur within 24hrs. Mortality is mainly associated with
left-sided perforation (annular or ventricular) and tamponade.
• Frequently, this requires emergency sternotomy

80. AORTIC ANNULAR OR ROOT RUPTURE
• Rupture due to the radial force of the prosthesis or balloon dilation can
occur at the annulus/root or LVOT.
• Rarely encountered, if it occurs it is frequently catastrophic on the
operating table. It is associated with area oversizing >20% and/or
asymmetric calcium extending into the LVOT particularly below the right
coronary leaflet.
• Balloon-expandable prostheses are typically involved rather than self-
expanding platforms
• Surgical intervention is inevitable although rare reports of TAV-in-TAV have
been performed

81. Other less frequent complications
• Valve malpositioning / embolization
• Valve dysfunction
• Valve thrombosis/ endocarditis
• Delayed embolisation

82. Non-cardiovascular complications
• Acute kidney injury – due to contrast and embolic calcium shower
• Hemolysis (secondary to patient-prosthesis mismatch)
• Acquired von-Willibrand disease – due to shear stress of vWF on the
valve
• Sepsis
• Radiation injury

83. Where does TAVR stand today? PARTNER 3
trial results (published in September 2019)
• Among low-risk patients with aortic stenosis, TAVR was superior to SAVR
at preventing death, stroke, or rehospitalization at 1 year.
• TAVR was also associated with a lower incidence of stroke and atrial
fibrillation, and a shorter hospital length of stay compared with SAVR.
• TAVR was also associated with a larger improvement in quality of life
compared with SAVR.
• There was a numerical increase in the need for new permanent pacemaker
within 30 days in the TAVR group (6.5% with TAVR vs. 4.0% with SAVR);
however, this difference was not statistically significant.
• Mild paravalvular aortic regurgitation occurred at a higher incidence in the
TAVR group. The incidence of moderate to severe aortic regurgitation was
rare (<1%) and similar between treatment groups.

84. SAPIEN Vs CoreValve (CHOICE study)
• The Comparison of Transcatheter Heart Valves in High Risk Patients
With Severe Aortic Stenosis (CHOICE) trial is the only head-to-head
comparison of CoreValve with SAPIEN XT (n=241).
• Using a composite endpoint for device success (successful vascular
access, delivery, deployment and retrieval of delivery system, correct
positioning of the device, intended performance according to echo
[aortic valve area >1.2cm2, and mean aortic valve gradient <20mmHg
or peak velocity<3m/s], and only one valve implanted in the proper
anatomical location) the result showed that the balloon-expandable
SAPIEN XT had a higher frequency of success

85. Newer advances in TAVI

86. TAV-in-SAV
• The first clinical case of TAVI for a degenerate surgical bioprosthesis was
performed with a CoreValve in 2007
• Currently this procedure is restricted to those for whom re-do surgery poses a
high risk as judged by the multidisciplinary Heart team.
• Although leaflet deterioration leading to stenosis or regurgitation represent the
mechanisms for surgical valve dysfunction it is important to know the precise
mode of surgical valve failure.
• Thrombosis and endocarditis are contraindications to TAVI and stenosis (as
opposed to regurgitation) is associated with worse procedural outcomes.
• Key aspects include ascertaining the true inner diameter of the base ring in
stented valves (as this is a rigid non-expansile portion of the valve), the degree
and location of any calcification, and the potential risk of coronary ostial
occlusion
• Pre-dilatation is not recommended but the remaining aspects of the
percutaneous procedure are similar to a conventional TAVI procedure with good
results from cumulative series of both SAPIEN and CoreValve platforms.
• Video

87. TAV-in-SAV for degenerated mitral
bioprosthesis

88. • A transcatheter valve inside a pre-existing TAV (TAV-in-TAV) is also
possible in case of device malpositioning/ degeneration
• TAVI for bicuspid aortic valve is considered a relative contraindication
due to a preponderance of asymmetrical calcium, low coronary ostia
and concurrent aortopathy affecting the ascending aorta (in which
case TAVI is contraindicated). TAVI is being performed in such cases as
well but the results are awaited

89. TAVI for isolated pure aortic regurgitation
• Percutaneous treatment of pure native aortic regurgitation is problematic
because the pathologies that afflict the aortic valve also frequently involve
the aortic root and ascending aorta mandating open surgical management.
• Furthermore, the absence of calcium in native regurgitation means that
conventional balloon-expandable and self-expanding platforms are less
able to anchor themselves securely within the aortic complex and the
anchor points themselves may not be within the annulus.
• To date only limited numbers of patients have undergone TAVI and a large
minority have had some degree of calcification in the aortic valvar complex

90. • To overcome these obstacles two pigtails can be used to identify the
annulus via the left and non-coronary sinuses (and thus more contrast is
typically used than in aortic stenosis procedures).
• If the anchor points are not within the annulus the valve may shorten and
lie within a supra-annular position. Excessive valve mobility is typically seen
and can be countered during deployment by rapid pacing.
• Despite this precaution there is a higher incidence of valve-in-valve
procedures (20%) compared to TAVI in aortic stenosis. Careful anatomical
planning is required particularly measurement of the ascending aorta as
this may act as a fixation point.
• The JenaValve is a percutaneous prosthesis design via the transapical
approach that has been approved specifically for native aortic regurgitation
and had encouraging early results

91. Devices in the pipeline
• Centera (trans-femoral)
• Trinity (motorised releasing device for accurate positioning)
• Colibri (pre-loaded device)
• Innovare (trans-apical)
• Optimum (minimal sutures, so larger EOA)
• Syntheon (fully automated release system)
• Biovalve (360 degree flexible delivery system)
• Edwards Helio-Dock – for pure AR

92. TAVI at NH
• First TAVI performed in September 2013 (CoreValve was used)
• Total TAVIs performed upto date – 73
• TAVIs in 2019 - 26
• Spectrum of valves used at NH
Valve used No. of cases
Corevalve 37
Sapien 3 16
Portico 12
Meril Myval 7
Hydra 1

93. What does the future hold?
Won-Keun Kim, Christian W. Hamm, The Future of TAVI, European Heart Journal, Volume 38, Issue 36,
21 September 2017, Pages 2704–2707

94. Predicted indication for TAVI in 2025

95. References
• PCR-EAPCI Textbook www.pcronline.com chapter on TAVI
• Technical aspects of transcatheter aortic valve implantation (TAVI) - An
article from the E-journal of Cardiology Practice Vol. 14, N° 5 - 08 Mar 2016
• YouTube videos
• Google images
• Individual company catalogues for valve information

96. Thank you