TAVI

TRANSCATHETER AORTIC VALVE
IMPLANTATION
(TAVI)
Dr.Nagula Praveen,
F i n a l y r P G

Contents
 Introduction
 History
 Screening of the patients
 Description of Edwards Sapien Valve
 Approaches for TAVI
 Complications
 Corevalve
 Complications
 Newer devices
 Take home message

Introduction
 TAVI is the most exciting advancement (an inexorable march) in
the field of interventional cardiology(percutaneous valve
therapeutics).
 First TAVI was a bail out procedure in an extremely high surgical
risk dying patient.
 TAVI as an indication for AS patients with low risk ,
intermediate risk for surgery is on uprise and will be available in
the near future.

History
 Transcatheter valvular interventions - exciting area for research
since 1960s.
 Initial animal investigations were performed by
Hywel Davies in 1965.
Moulopoulos in 1971
Phillips in 1976
Matsubara in 1992.
Temporary relief of aortic regurgitation.
 Concept of balloon expandable valvular prosthesis from the
endovascular stents.
 In 1992, Andersen et al, porcine model, transluminal stented heart
valve.

Transcatheter Aortic Valve Implantation (TAVI)
1992: Henning Andersen
First description of valve
sutured in stent
Animal model(pig)
Encountered major
limitations
Obstruction of coronary
ostia
Handmade wire frame to which was sewn a porcine valve.

 1994 – cadaver work – ability to deploy a palmaz stent in the aortic
position and contributed to appropriate stent dimensions.
 1999 – Percutaneous Valve Technologies, Fort Lee,NJ – an
original catheter was developed and tested in the sheep model.
 In 2000, Bonhoeffer and coworkers – valve from bovine jugular
vein mounted within an expendable stent -- native pulmonary valve
of the lambs.
 Later first successful human percutaneous replacement of a
pulmonary valve in an RV-PA prosthetic conduit with valve
dysfunction.

 First TAVI in a human was performed in 2002(April 16).
 Acquisition of PVT by Edwards Life Sciences in 2003 – Cribier
Edwards and the EDWARDS-SAPIEN Heart valve further
modifications of the original device was done.
 Feasibility of the TAVI in further studies.
 Grube et al - self expanding Core Valve Revalving system was
reported 2005.
 2010 – commercially available in Europe.
 Presently
>50 procedures/week

Dr.Alain Cribier
Dr.Helene Eltchaninoff
Dr.John Webb

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

 CE approval 2007.
 Edwards SAPIEN valve FDA approval Novmeber 2,2011.
 Edwards SAPIEN XT – 2014.
 Edwards SAPIEN 3 – June 17,2015.
 CE approval for Corevalve 2007
 FDA approval for Corevalve 2014.
 Corevalve EVOLUT – CE mark -2012.
 Jena valve and ABSOLUT valve CE approval for TA approach.

Risk stratification
 High risk for surgical complications - age or comorbidities.
 High operative risk (scores in the upper decile for mortality or
have a 30-day mortality >15%).
 Surgical risk is most commonly estimated by the Society of
Thoracic Surgery Predicted Risk of Mortality (STS- PROM) and
the European System for Cardiac Operative Risk Evaluation
(Euro SCORE).
 Euro SCORE – validated in patients undergoing valve surgery.
 Logistic Euro SCORE – Persistently overestimate the mortality
rate. the risk score divided by 3 – accepted true risk comparable
to STS score.

STS PROM score
 Derived from the STS database.
 Voluntary registry of practice outcomes, which estimates the risks
of mortality, morbidity, renal failure, and length of stay after
valvular and nonvalvular cardiac surgeries.
 Underestimates the true mortality rate after the cardiac surgery.
 Truly reflects the operative and 30 day mortality for the highest
risk patients undergoing aortic valve replacement.
 2011 updated score – is especially for TAVR – includes liver
disease assessed by MELD score,previous radiation
therapy,porcelain aorta,oxygen dependence.
 http://riskcalc.sts.org/stswebriskcalc/#/calculate

Limitations of EuroSCORE
Donot include certain characteristics that would complicate
surgery and increase operative mortality, such as
 Previous mediastinal irradiation
 Presence of severe calcification in the thoracic aorta(porcelain
aorta)
 Anatomic abnormality of the chest wall
 History of mediastinitis
 Liver cirrhosis
 Patient’s frailty
Algorithms were calculated from patients who underwent surgery.
 Applicability to patients who were not surgical candidates ?

Frailty Index
 Modified Fried frailty index.
 4 criteria
 ≥ 2/4 criteria among the following:
 ≥ 2/6 Activity of Daily Living (ADL) impairment
 Serum albumin < 3.5 g/dl
 Grip strength < 30 kg for male,< 18 kg for female
 15 feet walk test ≥ 7 seconds.
 Each criterion is scored in quartiles (0-3)
 Total score 0-12 .
 Frailty score > 5 had a > 7 fold increase in 1 yr mortality after TAVR.
 Multicenter FRAILTY AVR study.
400 SAVR vs 400 TAVR
>70 yrs age
7 frailty assessment tools
Dr.Linda P. Fried

Screening of the patients
PARTNER trial cohort
 Severe symptomatic AS
 High risk for surgical complications (STS risk score >10%)
 Have a greater than 1 yr survival with regard to their
comorbidities, and might benefit from the valve replacement.
EUROPE UNION COUNTRIES
 Patients with severe AS( valve area < 0.8 cm² )
 High surgical risk (Logistic Euroscore >20%)
 Contraindication to conventional AVR

Preliminary evaluation
 Screening echocardiography to document
 The severity of AS.
 Absence of other severe valvular disease
 Describe the valve anatomy and calcium distribution
 Determine the aortic annular diameter and left ventricular function.
 Right and left heart catheterization
 Presence of pulmonary hypertension and concomitant CAD
 If present need to be treated before valve implantation.
 Aortic angiography
 Correct orientation of the image intensifier during valve positioning
 Determine potential complicating factors in the aortic arch that may interfere during
the procedure.
 Thoraco abdominal CT angiography
 Ilio femoral run off – anatomy of aorta,vessel diameter ,calcification and tortuosity.

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

Vascular screening
 Route of implantation needs to be determined.
 Both delivery methods are comparable in success and complication rates.
 Selection depends upon the tortuosity, calcification and internal diameter
of the femoral,external iliac and common iliac arteries.
 Presence of abdominal aortic aneurysm or history of their repair - - - use
of the trans apical approach or the subclavian approach.
 Vascular complications – significant mortality.
 Contrast angiography – appropriate screening tool for route selection.
Core Valve Revalving system Femoral
Subclavian approach
Edwards SAPIEN heart valve Trans apical
Trans femoral

Vascular screening
 Detailed determination of the vascular anatomy is not possible with
contrast angiography.
 Insertion of a guidewire across the iliac arteries – the degree that the
vessels will straighten can be evaluated.
 If the arteries persist with tortuosity – TA or subclavian approach
can be preferred.
 CTA – degree, extent and localisation of vascular calcification.
 3D vessel reconstruction and cross sectional imaging – precise
determination of vessel lumen diameter.
 Minimal luminal diameter and the length of the segment with the
MLD are the main considerations for selecting the delivery approach
 IVUS – invasive way of measuring the arterial diameter. – image
obliquity.

Vascular screening
Valve size Sheath size Minimal arterial diameter
Edwards SAPIEN
23 mm 22 French (F) 7 mm
26 mm 24 F 8 mm
Edwards SAPIEN XT
23 mm 18F 6 mm
26 mm 19F 6.5 mm
Medtronic Core valve 18 F 6 mm

Recent developments
 MDCT – reliable and reproducible imaging modality for optimal
prosthesis sizing, especially in patients with an eccentric annulus.
 CT imaging > TEE > TTE – annular diameter.
 3D TEE – risk of significant AR post operatively
 Annular area – prosthesis area = prosthesis annular discongruence.
 3D rotational angiography
 Paieon C THV system
 3 mensio valve system
 Dyna CT of SIEMENS – processing of 2D iamges acquired in the
cath lab by a C ARM system.

Vascular access sites
TRANSFEMORAL TRANSAPICAL TRANSAORTIC
TRANS SUBCLAVIAN TRANSAXILLARY
TRANSSEPTAL
RETROPERITONEAL
TRANSCAROTID
Are the latest access sites applicable
for TAVI

THV
1st
generation
Cribier
Edwards
Valve
Edwards SAPIEN
valve
Edwards
SAPIEN XT
valve
Edwards
SAPIEN 3
valve
Self
expanding
valve
Medtronic
Core Valve
2nd
generation
Boston Scientific -LOTUS valve
Direct Flow Medical Valve
Heart Leaflet Technologies valve
Symetis Accurate valve (CE MARK)
Jena valve (CE MARK )
Engager valve
CENTERA
Core valve EVOLUT
COLIBRI valve
REPOSTIONABLE AorTX
Trinity FLEXX valve
UCL TAV
VANGUARD II VALVE
OPTIMUM TAV – for BAV
Nanotechnology bsed THV
Autologous engineered valves
 Can be repositioned
 Easy deployment
 Less risk of conduction
disturbances
 Less risk of PVR
 14 F sheaths

Valve Academic Research Consortium Outcomes
Recently updated VARC 2 definitions
Eur J Cardiothorac Surg. 2012 Nov;42(5):S45-60. doi:
10.1093/ejcts/ezs533. Epub 2012 Oct 1.
Updated standardized endpoint definitions for transcatheter aortic
valve implantation: the Valve Academic Research Consortium-2
consensus document (VARC-2)

EDWARDS LIFE SCIENCES
TRANSCATHETER HEART
VALVE (THV)
Edwards Life Sciences,Irvine,California.

Cribier-Edwards percutaneous valve.
John G. Webb et al. Circulation. 2006;113:842-850
Copyright © American Heart Association, Inc. All rights reserved.
Laser cut stainless steel
tubular frame
Within which was sewn
valve leaflets
Constructed from
equine pericardium,
with the inflow covered
with a fabric
sealing cuff.

EDWARDS SAPIEN VALVE
 Consists of a bioprosthetic valve, the balloon catheter on which it
is mounted, the retroflex catheter and the crimping tool.
 Tri leaflet bioprsothesis
 Bovine perciardium
 Balloon expandable stainless steel stent.
 Pre treated to decrease calcification and functional deterioration.

 Fabric cuff – on the ventricular side
 Covers one half of the frame
 Limits stent expansion
 Decreases perivalvular insufficiency
 Oversizing to the aortic annulus – post deployment stability –
lack of a sewing ring.
 Durability of the valve > 10 yrs
 Advantages :
 larger effective orifice area,
 lower hemodynamic profile compared with corresponding
surgically implanted valves,
 Disdavantage : higher incidence of perivalvular insufficiency.
23 mm stent height 14.5 mm
26 mm height 16 mm

EDWARDS SAPIEN XT
 Currently commercially available in Europe.
 Cobalt chromium alloy.
 Same radial strength while reducing the valve profile.
 Approved for the TF approach and is under investigation for the
TA approach.
 In the future,21 mm and 29 mm valves will be available.

Figure 2. A, Femoral
sheath and dilator.
B, The deflection
catheter facilitates
delivery of the
prosthetic valve to
the aortic annulus.

Balloon catheter
 Custom made balloon
 30 mm in length.
 Balloon diameters corresponding to the sizes of prostheses,and
ends in a nose cone that facilitates crossing the native valve.
 Its inflation profile decreases movement during inflation.

The crimping tool
 Used to manually and symmetrically compress the overall
diameter of PHV – from expanded size to minimal deliver
profile.
 A cylindrical gauge is used to confirm the collapsed profile of the
delivery system to ensure that it will move smoothly through the
introducer sheath.
 A measuring ring is used to calibrate the balloon inflation to its
desired size and to determine the amount of saline – contrast
mixture in the syringe necessary for the proper inflation at the
time of deployment.

Retroflex Guiding catheter
 Initially developed by Webb.
 An innovation to facilitate the PHV passage across the aortic
arch from the retrograde approach.
 Deflectable tip - changes direction when activated by the
rotation of an actuator incorporated in the handle.
 Provides a less traumatic passage to the valve delivery system.
 Asssits in centering and supporting the valve as it crosses the
calcified and stenotic native valve.
 Precise positioning at the aortic annulus.

Novaflex catheter
 Newer generation catheter
 Allows loading the Edwards- SAPIEN XT prosthesis onto the
balloon while in the body, decreasing the sheath size
dramatically.

Ascendra delivery system
 Delivery system used for the trans apical route.
 Easy valve manipulation to improve the orientation of the
prosthesis.

Delivery sheath
 25 cm hydrophilic coated sheath.
 Extends into the abdominal aorta to decrease vascular
complications.
 Transfemoral delivery
 Sheaths are equipped with a hemostatic mechanism to decrease
blood loss.
 Transapical delivery sheath is 26F in diameter, is shorter,and has a
flexible tip to decrease trauma when placed in the LV.
EDWARDS SAPIEN 23 mm 22F
26mm 24F
EDWARDS SAPIEN XT 18F
NOVOFLEX 19F

Expandable sheaths
 “Snake swallowing the prey concept”
 esheath (Edwards)
 Allows the valve delivery system to stretch within the sheath as it
is advanced through the femoral and iliac artery, until it reaches
the abdominal aorta.
Sheath Valves enclosed
16Fr 23 mm SAPIEN XT

TRANS FEMORAL VALVE
IMPLANTATION

Steps of the Procedure
 Patient preparation
 Equipment
 Antibiotic prophylaxis.
 Venous and arterial access
 Imaging
 RVP
 BAV
 TAVI
 Post procedure assessment

Room requirements:
 Cardiac cath lab or hybrid operating room.
 Fixed flouroscopy unit – high image quality, ability to store
reference images for roadmapping.
 Cardiopulmonary bypass machine should be accessible.
 Equipment to treat vascular or coronary complications.
Anaesthesia:
 General anaesthesia if simultaneous TEE is performed.
 Conscious sedation and local anaesthesia if no TEE.
 Continuous hemodynamic monitoring required.
 Vasopressores should be used judiciously,as vasoconstrictiors may
interfere with the insertion and removal of the arterial sheath –
vascular complications.

Infection and antithrombotic prophylaxis:
 IV antibiotics before procedure – 48 hrs later
(Vancomycin,cefazolin).
 Aspirin 160 -325 mg and clopidogrel 300 mg are administered
alteast 24 hours before the procedure.
 After procedure,clopidogrel 75 mg daily is continued for 1 to 6
months and daily apsirin 75mg indefinitely.

Venous and arterial access:
Ipsilateral leg
Femoral arterial access 5F or 6F pigtail catheter Aortic angiography
Femoral vein access RVP
Contralateral leg
Percutaneously Two suture mediated devices
Surgical cut down Common femoral artery not
to be completely dissected in
the posterior aspect
Sheath insertion is easier
Percutaneously 10 F device Edwards SAPIEN X T device

Aortic angiography:
 Ideal projection is all of the aortic cusps in line and perpendicular to the
image intensifier.
Temporary Pacemaker Placement:
 6F Soloist lead is placed in the right ventricle.
 RVP at a rate of 180 -220 bpm.
Crossing the aortic valve:
 After anticoagulation with heparin and a therapeutic ACT is
confirmed,the native aortic valve is crossed using an AL-2 catheter and a
straight guidewire.
 Extrastiff IA is then exchanged through the AL-2 .
 Catheter withdrawn distal wire position is maintained in the LV.
 Pigtail catheter is advanced and the valve gradient is then obtained.

Delivery sheath insertion:
 With guidewire in LA,the previously inserted 8F sheath is removed.
 Serial dilatation of the femoral and iliac arteries are performed with
arterial dilators of increasing size(16F-25F).
 Delivery sheath is inserted and positioned in the descending aorta.
Balloon aortic valvuloplasty:
 under RVP,before TAVI.
 Valve prosthesis should be ready to be inserted before the
completion of the BAV in case severe AR and hemodynamic
instability develop.
20 mm Balloon 23 mm Valve
23 mm Balloon 26 mm valve

Figure 3. A, The prosthesis could not be advanced around the aortic arch.
B, Active deflection allowed redirection around the arch and access to the
ascending aorta. Fluoroscopy in the left anterior oblique projection may aid in
negotiating the aortic arch.

Valve insertion and deployment:
 Prosthesis and the delivery system are then inserted in the sheath
over the extra stiff guide wire.
 Once the delivery system reaches the aortic arch,the retroflex
catheter is activated,allowing the safe passage of the delivery
system across the aortic arch.
 System advanced to ascending aorta.
 In the same projection as before(aortic annulus is perpendicular to
the screen,the valve is positioned in the aortic position,maintaining
a 60%:40% ratio of ventricular :aortic positioning.
 Midline of the stent frame level with aortic annulus
 Appropriate location with angiography and TEE – the valve is
deployed under RVP.

Figure 4. A, The prosthesis could not be advanced through the
commissure of the native valve.
B, The active deflection catheter facilitates redirection through the valve
orifice.
C, The prosthesis is carefully positioned adjacent to the calcified native
aortic valve.

 The valve is deployed after the confirmation that the systemic blood
pressure has reached and maintained its nadir.
 Balloon inflation is held 3-5 seconds before deflation.
 RVP is then stopped to avoid traction on the prosthesis while the
balloon catheter is being withdrawn.
 RVP run generally does not last longer than 15 seconds.
 Delivery system is straightened and withdrawn.
 Trans valvular gradient is measured and paravalvular leaks are
evaluated by angiography and echocardiography.

ECG and femoral arterial pressure monitor display.
ECG and femoral arterial pressure monitor display.
Rapid right ventricular pacing reduces transvalvular pulsatile flow
during balloon inflation.
In this case, initial 2:1 capture is followed by delayed 1:1 capture with a
greater fall in arterial pressure.

Figure 6. A, Balloon-mounted prosthetic valve positioned adjacent to native
valve calcification.
B, Partial inflation of the deployment balloon.
C, Full inflation of the deployment balloon.

A. Ascending aortograms obtained in the posteroanterior projection.
B. After prosthetic valve implantation. The prosthesis is positioned below
the ostia of the coronary arteries. There is no aortic insufficiency.

Sheath Removal and Arteriotomy closure:
 Sheath is withdrawn with careful monitoring of blood pressure
and simultaneous contrast administration through the pigtail
catheter placed at the level of the iliac bifurcation.
 A precipituous drop in BP or extravasation of contrast media
indicates vascular rupture.
 Complication treated by – covered stent or surgical repair.
 Immediate tamponade of the ruptured vessel with large
sheath,closure of the iliac artery or abdominal aorta with a large
size balloon – before arterial repair.
 Arteriotomy site –closed surgically or percutaneously

Postmortem photograph showing the prosthetic stent adjacent to a bulky,
calcified native leaflet excrescence.

Transfemoral Approach Sapien Valve
77
RetroFlex 3 introducer Sheath Set
Edwards SAPIEN THV
RetroFlex Balloon Catheter
RetroFlex Dilator Kit

Hardware
CrimperDilator set Inflation device

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

Differences
 A small left lateral thoracotomy is performed.
 Planes are dissected until the left ventricular apex is visualised.
 Purse string suture is placed in a muscular segment of the apico lateral
wall.
 Direct puncture of the LV after anticoagulation and therapeutic ACT
achieved, a 7F or a 8F sheath is inserted into the LV.
 0.035 inch J tipped guidewire,then advanced through the valve into the
descending aorta while being guided with JR curve catheter.
 The wire must be free of the papillary muscles or mitral chordal
structures to avoid complications after insertion of the delivery sheath.
 The wire exchanged for an extra stiff wire, the amplatz 0.035
inch,270cm long guidewire and the JR catheter is removed.

 Sheath is exchanged for a 26 F delivery sheath – inserted 3-4 cm into
the LV.
 Under RVP,a BAV is performed with a 20 cm retroflex balloon.
 Ascendra delivery system is advanced into the sheath and de aired.
 The valve catheter ensemble is advanced into the aortic position,
maintaining a ratio of 50:50 aortic :ventricular positioning.
 RVP and a patient breath hold are initiated.
 Valve is deployed as blood pressure is at its nadir.
 Balloon is deflated and withdrawn.
 Ventricular sheath is removed after assessing the AR.
 Thoracotomy is closed over a drain.

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

Transapical Approach
Direct left ventricular puncture
Placement and valve deployment

Apical access devices in pipeline
APICA system
 Coiling device to anchor to the apex.
 Sealing cap to close or reaccess the access site.
PERMA seal
 Sutureless device
 Collapsible polymers to spontaneously close the apex after the TA
delivery system is removed.

TRANSAORTIC
 Most direct access to the aortic valve.
Advantages:
 Avoids thoracotomy which potentially impedes pulmonary
function (COPD pts).
 Avoids injury to the myocardium and apex (low LVEF pts)
 Sheath placement easier and safer.
 Compatible with SAPIEN and Corevalve.
 Rapid cannulation of aorta and initiation of CP bypass.
C/I – significant aortic calcification.
 MDCT mandatory before procedure.
 Upper hemisternotomy and right anterior mini thoracotomy.
 Certitude system is the latest for TAo implantation

TRANSCAROTID
 First done in Emory university
 3 patients
 Edwards Retroflex 3 system was used.
 Corevalve implantation via left carotid artery done in 12 patients.
 Left carotid diameter > 7.5 mm adequate.

STROKE
HEART BLOCK AND ARRHYTHMIAS
RENAL DYSFUNCTION
SEVERE AORTIC INSUFFICIENCY
VALVE EMBOLIZATION
VASCULAR COMPLICATIONS
CORONARY OBSTRUCTION
Complications

Stroke
 General incidience is 2.5-4.2% .
 Lower with trans apical approach(assumption).
 Subclinical cases high with MRI screening.
 Cerebral embolization can occur during
 Passage of the valve across the aortic arch.
 During the attempt to traverse the aortic valve
 During BAV
 During valve implantation.
 Cerebral embolic protection devices during TAVI are being
evaluated.

Heart block
 Incidence of CHB requiring PPI 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

Other
 AF is seen in approx 12% after TAVI.
 CHB that requires pacemaker – 5.7%
 LBBB – 12%
 First degree AV block – 15%.
Cause:
 Trauma to conduction tissue –transient
 Myocyte necrosis in the IVS –permanent block.

Renal dysfunction
 AKI seen in 12%- 28%.
 Renal replacement therapy in 1.4%.
 Hypertension (OR 4.66)
 COPD (OR2.64)
 Transfusion requirement (OR 3.47)
 Mortality risk is increased (28% vs 7%)
 AKI and dialysis were less compared to surgery (9.2% vs 25% ,
2.5% vs 8.7%)

Severe AR
 VALVULAR
 PERIVALVULAR
 Valvular
 most commonly caused by guidewire and disappears once wire is
removed.
 Prosthetic malfunction – rare.
 Interference of native valve leaflets with prosthetic function.
 Placement of a new valve inside the previously placed valve.

Perivalvular insufficiency.
 Inappropriate sizing
 Malposition
 Stent underexpansion
 Post procedure dilatation with a large balloon size will cause
flaring of the aortic portion of the stent, conformation of the
ventricular portion is changed –worsens the AR.
 Stent skirt prevents further expansion.

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]

Date of download: 9/15/2015 Copyright © The American College of Cardiology. All rights reserved.
From: A Practical Guide to Multimodality Imaging of Transcatheter Aortic Valve Replacement
J Am Coll Cardiol Img. 2012;5(4):441-455. doi:10.1016/j.jcmg.2011.12.013
Grading Criteria for Paravalvular AR
(A) Schematic and illustrated representation of the short-axis view at the level of the aortic valve by echocardiography. (B)
Echocardiographic and schematic illustrations of the short-axis view of the aortic valve. Paravalvular aortic regurgitation (AR) can
be graded according to the circumferential extent of the regurgitant jet. Paravalvular AR can be graded as mild, moderate, or severe
on the basis of a circumferential extent of <10%, 10% to 20%, or >20%, respectively. See Leon et al. (55). RV, right ventricle. Image
credit: CC Patrick J. Lynch and C. Carl Jaffe, Yale University, 2006.
Figure Legend:

Measures to decrease perivalvular AR
 Decreased congruence between the aortic annulus and device
diameter.
 Low cover index.
 100 *(prosthesis diameter – TEE annulus diameter )
/prosthesis diameter.
 AR index = [(DBP − LVEDP)/SBP] × 100.
 Echocardiographic calcification score index
 Aortic annulus, sinotubular junction, and aortic valve
commissures
 Each commissure and cusp is given score.
 Score of 0 – 8.

Valve embolization
 Malposition
 Undersizing of the prosthesis.
 Inappropriate capture during RVP.
Embolization to LV – fatal.
 Aortic embolization occurs – not to remove the guidewire – distal
aorta.
 Inverted valve –does not allow passage of blood through it.
 Uniformly fatal.
 Aortic dissection chances are more after valve manipulation

Vascular complications
 6.6% of cases.
 Transfemoral approach 8% vs 3.6%
 Fatal with transapical approach.
 Small dissection
 Vascular perforation
 Vessel avulsion.
 Aortic annular tear - dissection

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

Coronary obstruction
 Subcoronary position
 0.6% cases
 Emergency revascularization

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.

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

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

 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
Mitral valve injury

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 protection
Aspirin, anticoagulants
Anticoagulation reversal, coagulopathy correction

MEDTRONIC
SELF EXPANDING
CORE VALVE
Dr.Eberhard Grube

 Three generations of the Corevalve Revalving systems have been
developed.
 Self expanding valve.
Delivery catheter
First generation 25 F Nitinol frame Bovine pericardial valve
Second generation 21 F Nitinol frame Porcine pericardial valve
Scalloped inflow portion –
better flow hemodynamics
Third generation 18 F Nitinol frame Skirt and leaflet into six
independent sections
Sections sewed onto nitinol
frame
CE MARK approval
in 2007
>10,000 impantations

Low profile ,increased durability

3 components
 Self expanding nitinol support frame – cells configured in a
diamond cell design, - anchors a trileaflet porcine pericardial
tissue valve.
 18 F delivery catheter.
 Disposable loading system.
Aortic annular size
26 mm 20-23 mm
29 mm 24-27 mm

Nitinol frame
 Radial and hoop strength.
 upper third (outflow) - low radial force : sits prosthesis in the
aortic root
 Parallel to the flow through the valve
 middle third(constrained center portion ) high hoop strength,valve
leaflets are attached avoid impinging the coronaries. (SUPRA
ANNULAR VALVE LEAFLETS)
 It is concave – allows coronary cannulation after implantation.
 lower third (inflow) - high radial expansive force and sits within
the left ventricular outflow tract /aortic annuluar location.
 Prevents annular recoil
 Allows to conform to the noncircular shape of the aortic annulus.
 Prevents frame migration
 Minimizes paravalvular leaks

 The three leaflet elements – long commissures –suspension bridge –
uniform distribution of the aortic pressure overload to the valve leaflets
and the commissural posts.
 Angled take off of the posts further reduces stress and optimizes leaflet
motion.
 The ability to maintain functionality in a non round shape at the inflow
is a critical feature of CRS,constrained part maintains the circular
configuration.

Anatomic pathologic findings after corevalve
implantation
 4 patients
 350 days after implantation
 Fibrin deposition and inflammation occur early after implantation.
 Neointimal coverage and progressive regression of the
inflammatory response over time.
 Neointimal tissue covers the most of the frame struts in contact
with aortic wall but in areas of high velocity of blood flow.
 No excessive pannus formation occuring over the valve leaflets.
 No fractures of the nitinol frame struts upto 2 yrs – angiographic
imaging.

Patient selection
Clinical contraindications to Corevalve placement –
 Sepsis
 Active endocarditis
 Uncontrolled AF
 Severe MR,TR,PR
 Life expectancy less than 1 yr.
Relative –
 Gastritis,peptic ulcer disease, severe renal
insufficiency,uncontrolled bleeding diathesis, symptomatic CAD,
abdominal or thoracic aortic anuerysm.
 LVEF < 20%

Anatomic criteria
 Careful evaluation of the aortoannular complex with imaging
studies before the procedure.
 TTE,TEE – preliminary
 CTA – true aortic annular area.
 Vascular criteria
 access vessel diameter > 6 mm.
 Severe calcification and vessel tortuosity,the access vessel
diameter > 7 mm.
 CTA is the best for evaluation

Diagnositc findings Recommended Not recommended
LVH Normal to moderate 0.6-1.6 cm Severe >1.7 cm
CAD None;mid or distal >70% Proximal lesions >70%
Aortic arch angulation Large radial turn Sharp turn
Aortic root angulation <30 degrees 30-45 degrees
Aortic and vascular disease No or light vascular disease Moderate vascular disease
Vascular access diameter >6 mm Calcified and elongated >7
mm
Sinus of valsalva width ≥27 mm (26 mm corevalve)
≥29 mm (29 mm corevalve)
<27 mm
<29 mm
Sinus of valvsalva height ≥15 mm <15 mm
Ascending aorta diameter ≤40 mm
≤43 mm
>40 mm
>43 mm
Annulus diameter 20-23 mm
24-27 mm
<20 or >23 mm
<24 or >27 mm
No atrial or ventricular thrombus
No subaortic stenosis
LVEF >20%
<2 + MR

Procedure
 Pretreatment with aspirin,clopidogrel
 Antibiotic coverage atleast 1 hr before the procedure.
 General anaesthesia or conscious sedation.
 Temporary 5F pacing lead in RV.
 Arterial access is then obtained on the contralateral side to the planned 18
F sheath for the CRS.
 Ultrasounded and angiographic guide for arterial puncture.
 ACT of 250 seconds or more.
 Pigtail catheter in NCC of the aorta.
 LAO projection.
 Angiographic catheter –advance over the standard j tip guide wire into the
ascending aorta.
 Guidewire is exchanged with the straight tip wire to cross the aortic valve
- catheter into LV.
 Extras stiff wire is passed into the LV –positioned at LV apex.

 Balloon valvuloplasty is performed under RVP.
 1:1 sizing (minimal aortic annular diameter by CTA,echo)
 Maximum size is 25mm balloon.
 Corevalve advanced over the 0.035 inch guidewire and positioned
across the aortic valve.
 Aortography to assess the most inferior aspect of the valvular plane.
 Inflow portion of the corevalve within the aortic annulus.(<6mm below
the annulus).
 Inflow portion flaring out is assessed by sequential aortography
 Residual stenosis and AR.
 Removal of vascular sheath – percutaneous closure
 Cardiac ICU monitoring for 48 hours.
 Aspirin ,clopidogrel combination for 3 months after procedure.

Vascular sites
 Subclavian access
 Italian National Registry 54 cases
 100% procedural success noted with Core Valve.
 No specific complications noted
 No deaths at 30 days in the series.
 6 month mortality was 9.4%(same as transfemoral approach).
 Adequate vessel caliber is needed –dissection ,left arm
paralysis.
 Transaortic

Valve in Valve
 Degenerative bioprosthetic valve
 Stenotic 21mm aortic bioprosthesis
 Has been successfully implanted in patients with prior
mechanical mitral valve prosthesis.(previously considered as a
contraindication.

Recent trends in using THV
 Valve in transcatheter valve
 Valve in aortic bioprosthetic valve
 Valve in mitral valve
 Valve in double valve
 Valve in tricuspid valve
 Valve in ring

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

TAVI in a patient with a history of mitral valve
replacement

Valve-in-valve
TAVI in both Stented and
stentless bioprosthetic valve
dysfunction

Complications
 The Valve Academic Research Consortium (VARC) has
developed standardized definitions for outcome after TAVI
 These criteria will form the evidence base for studies in the
future.
Complications (VARC)
Strokes and Transient Ischemic attacks
Vascular access complications
Conduction system disturbances
Coronary artery occlusion
Acute renal failure

Strokes and TIA
 Approximately 5% of patients after traditional surgical AVR.
 Similar rates after CoreValve placement.
 Etiology of CVAs after TAVI – Embolization of atherothrombotic
material during advancement of the device to and across the aortic
valve.
 Microembolization is common after TAVI.
 Clinical strokes are infrequent (2.9% -5.1%).
 If TIAs are included the rate may increase.
Novel embolic protection devices to protect the cerebral circulation
are under development.

 Determination of the etiology of AR after Corevalve placement
is an important factor in determining both its significance and
its treatment.
 Paravalvular leaks – uncommon after CoreValve TAVI.
 Low positioning of the CoreValve frame
 Incomplete expansion of the frame into the eccentrically shaped annulus
 Rigidity of the underlying aortic annulus caused by calcification
 Undersizing of the valve relative to the aortic annular size.
 Post deployment valvuloplasty may be useful.
 Retraction of the frame loops using a retrieval snare.

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’

 Higher degrees of post implantation AR (>2+) - worse clinical
outcome - low cardiac output, respiratory failure delirium,
new onset LBBB, in hospital death.

Vascular access complications
 Because of the relatively large 18F caliber sheath.
 Incidence varied from 4% to 13%.
 91 consecutive patients – 13 patients (13% ) vascular events
 7 events were related to incomplete arteriotomy closure with
the Prostar device.
 Meticulous pre procedural screening using CTA
 Use of vascular ultrasound guidance for arterial access
 Use of alternative access (subclavian)

Conduction system disturbances
 Latent and manifest conduction disease in the bundle of His
and the tri fascicular conduction system.
 More extensive with calcified valves and greater valve
obstruction.
 Location of the AV node and origin of the left bundle adjacent
to the junction of the RCC and NCC, irritation of
membranous septum can affect AV conduction.
a | The anatomy of the aortic root, valve, and conduction system in the normal heart. b | Leaflet
fusion, as seen with aortic stenosis, results in reduced (annular) attachment of the valve, with
reduction of the interleaflet triangle size. c | Position of the Medtronic CoreValve® system in the
native aortic valve.
Abbreviations: L, left coronary sinus; LBB, left bundle branch; LFT, left fibrous trigone; MS,
membranous septum; MV, mitral valve; N, noncoronary sinus; R, right coronary sinus; RFT, right
fibrous trigone; STJ, sintotubular junction; VAJ, ventriculoarterial junction; VS, ventricular
septum.
Permission obtained from Wolters Kluwer Health © Khawaja, M. Z. et al. Permanent pacemaker
insertion after CoreValve transcatheter aortic valve implantation: incidence and contributing

Coronary occlusion
 Rare <1%
 Distance between the aortic annulus and coronaries are
reduced in patients with AS.

Differences between two valves
head to head comparison

Other Prostheses
Second generation trans catheter aortic valve prototypes
Lotus 117(Sadra Medical,Saratoga,CA)
AorTx (Palo Alta,CA)
Jenna Valve
Direct Flow (Santa Rosa,CA)
Paniagua

Newly approved TransApical devices

Future directions
 Catheter based valve implantation to treat bioprosthetic valve
dysfunction.
 New stent anchoring systems may be developed to treat aortic
insufficiency as well.
 Development of embolic protection devices
 In vivo prosthetic valve durability
 Clinical consequences of chronic perivalvular insufficiency will
be answered.

Conclusion
 Catheter based treatment of aortic stenosis is improving.
 Restenosis after valvuloplasty has been overcome after
development of TAVI.
 Indications for TAVI can be expanded after the availability of
follow up of patients of the cohort.
 Team approach for successful procedure.
 Training required for performance of TAVI and dedicated
imaging instruments.
 Patient selection is complex.

Take home message
 Selection of patients, evaluation is more extensive in TAVI,
procedure is complex – but good results.
 Surgical AVR still is the treatment of choice for patients with
severe symptomatic AS.
 In inoperable or high risk patient,TAVI is a reality, may be
extended to intermediate risk and low risk patients.

TAVI

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