S T V H

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SURGICAL
TREATMENT FOR
VALVULAR HEART
DISEASE
1
Susan Raaymakers, MPAS, PA-C, RDCS (AE)(PE)
Grand Valley State University, Grand Rapids, Michigan
[email protected]
BACKGROUND

Review

Rheumatic heart dz originates as throat infection from
streptococcal infection


Article in January 2009 JASE
Rheumatic heart disease was the leading cause of death
100 years ago in people aged 5-20 years in the United
States

Incidence just above 0% in developed countries

Chronic rheumatic heart disease is estimated to exist in 5-30
million children and young adults; 90,000 patients die from this
disease each year. The mortality rate from this disease remains 110%

Occurs generally in children 5-15 years old but may present in
adult
http://www.emedicine.com/ped/topic2007.htm
2
INITIAL SURGICAL TREATMENTS

First successful attempt at surgical treatment

Incising the left atrial appendage, placing finger
through the incision into the left atrium, feeling the
stenotic mitral and relieving the obstruction by
simple finger pressure.
3
INITIAL SURGICAL TREATMENTS

In the early days of cardiovascular surgery,
procedures were done on the beating heart

1950’s cardiac and pulmonary bypass machines were
developed



This development made it possible to keep the patient alive
while stopping the heart for surgical repair
Ability to stop the heart allowed examination of valve
pathology and repair
Stimulated surgeons’ collaboration with mechanical
engineers in developing prosthetic valves
Erector set heart pump, 1950
Using a toy Erector set, William Sewell Jr. and William W. L.
Glenn, Yale University medical students, built this section of a
heart pump, which Sewell successfully used in experimental
bypass surgery on dogs. Acquired in 1959 from Sewell's
mother, this heart pump is one of many invention prototypes
in the Smithsonian collections
4
INDICATIONS FOR
SURGICAL
REPAIR/REPLACEMENT
OF
VALVES
5
FIRST GENERATION OF SYNTHETIC
VALVES

Era of valve surgery proceeded the development of
echocardiography by only a few years. 1960s


One of the earliest applications of echocardiography was the
evaluation of prosthetic valves.
The first generation of synthetic valves retained in a
cage


Free-floating balls (mechanical ball and cage) or
Disc occluders (caged disk)
6
INDICATIONS
Valvular stenosis
 Valvular regurgitation
 Native valve endocarditis
 Aortic dissection with severe aortic regurgitation

7
VALVULAR REPLACEMENT
8
9
THREE TYPES OF
PROSTHETIC HEART
VALVES
10
THREE TYPES OF PROSTHETIC
HEART VALVES
Mechanical
Bioprosthetic
Homograft
11
MECHANICAL VALVES
All
mechanical valves have
A Sewing ring
Moving component
Cage, strut or frame.
Made
from a compressed carbon
material
•
•
Hard enough and yet free of significant friction to
provide long term durability
Providing relative freedom from wear, breakage or
excessive clotting.
MECHANICAL VALVES
TYPES
Ball and Cage
 Caged Disc
 Tilting Disc
 Bileaflet
 Valved Conduit

13
MECHANICAL VALVE
BALL AND CAGE
14
MECHANICAL VALVES
BALL AND CAGE
 Starr-Edwards
(used in the first
clinically successful valve replacement)

Was most Common
 Smeloff-Cutter
 Braunwald-Cutter
 Magovern-Surgitool
 Magovern-Cromie
 Harken
 DeBakey-Surgitool
 Hufnagel
15
MECHANICAL BALL AND CAGE
To open, the ball moves forward into the cage, allowing blood flow around the
entire circumference. To occlude, the ball is driven back into the sewing ring to
prevent backflow.
Hufnagel
1952
Smeloff-Cutter
Starr-Edwards in Mitral
16
Position – introduced
1961
STARR-EDWARDS VALVE IN
MITRAL POSITION
•poppit
•moving forward and
backward in the cage.
•Diastole,
•poppet moves forward
allowing blood to flow
around the occluder.
•These valves are highly
echogenic, and small thrombi
or vegetations can be easily
hidden or overlooked.
17
14.5 Feigenbaum
FLOW PROFILE
BALL AND CAGE
 Open

position
Blood flows across sewing ring and around the ball
occluder on all sides

In Colorflow, observed as bilateral horns.
 Closed

position
Small amount of regurgitation: circumferentially
around the ball as it seats in the sewing ring
18
M-MODE STARR-EDWARDS FROM
APEX
19
SHORT-COMINGS OF BALL AND CAGE
1.
Bulky in design and did not fit well into
a small ventricle or aorta
2.
Small internal orifice, making them
relatively stenotic
3.
Stimulated thrombus formation, which
precipitated thromboembolic events,
necessitating long-term anti-coagulation
therapy
20
MECHANICAL VALVE
CAGED DISC
21
MECHANICAL VALVE - CAGED DISC
NO LONGER IN USE

Beall-Surgitool

Was the most common
Kay-Shiley
 Kay-Suzuki
 Cooley-Cutter
 Cross-Jones

22
MECHANICAL VALVE - CAGED DISC
Disc elevated by very
slight pressure to
Movable disc (discoid) demonstrate closure
Beall-Surgitool
Cooley-Cutter
23
MECHANICAL VALVE - CAGED DISC

Advantage over ball and cage


Caged disc occupied less area
Disadvantage

Similar to ball and cage
Tissue overgrowth
 Chipping of the disc due to constant impact
 Mechanical problems

24
MECHANICAL VALVE
SINGLE TILTING DISC
25
MECHANICAL VALVE
SINGLE TILTING DISC
 Most


common
Medtronic-Hall
Björk-Shiley

No longer available in U.S. due to the problem of strut
fracture
 Other





tilting discs
Lillehei-Kaster
Hall-Kaster
Wada-Cutter
Omniscience
Omnicarbon
Van der Spuy "toilet seat" valve
Blood tended to clot at the spring pivot of this
26 valve.
http://www.hhmi.org/biointeractive/museum/exhibit98/content/h12info.html
MECHANICAL VALVE
SINGLE TILTING DISC
•Single disk prosthesis
•Round sewing ring and a circular disk fixed eccentrically to the ring
via a hinge.
• Disk moves through an arc of less than 90º allows:
•Antegrade flow in the open position
•Seating within the sewing ring to prevent backflow in the closed
position.
Björk-Shiley (1971 First
Successful Tilting Disk)
Medtronic-Hall Pivoting
27
Disc Valve
FLOW PROFILE – SINGLE TILTING DISK
 Open
position

Two orifices of unequal size (major vs. minor)

Asymmetric flow profile as blood accelerates along
the tiled surface of the open disk

Subtle variations dependent on shape of disk
(concave vs. convex) and sewing ring design
 Closed

position
Small central jet of regurgitation occurs around the
central hole
28
COMPLICATIONS OF SINGLE
TILTING DISCS
 Björk-Shiley
had issues with strut fractures
619 of the 80,000 convexo-concave valves
implanted fractured with patient death in 2/3 of
cases
 FDA removed from market in 1986
 Perhaps the most infamous recall case on record

 Hinge
is eccentrically positioned within the
sewing ring and the disk opens less than 90
degrees.

Major and minor orifices are created and some
stagnation of flow occurs behind the disk.
29
BJORK-SHILEY
30
SINGLE TILTING DISCS

Advantage


Low profile, can be inserted into aortic and mitral
positions
Disadvantage


High degree of leakage around central strut
Region of stagnation behind disc


Thrombus formation
Tissue overgrowth
31
MECHANICAL VALVE
BILEAFLET
32
MECHANICAL VALVE - BILEAFLET

St. Jude
Most frequently used mechanic valve
 Three orifices, which promote central flow
 Least stenotic mechanical prosthetic valve

Carbomedics
 Duromedics (Hemex)
 Gott-Daggett

33
Non-dynamic
MECHANICAL VALVE - BILEAFLET
• Opening angle is generally more vertical (approx 80º) than single
disk prosthesis
• Results in three distinct orifices:
• Two larger ones on either side and a smaller central
rectangular-shaped orifice.
St. Jude
hyperlink
Carbomedics
34
ST. JUDE MITRAL PROSTHESIS
35
BI-LEAFLET MECHANIC VALVE

Colorflow profile
Single large flow pattern or
 Two major jets on sides and one minor in middle.

36
FLOW PROFILE - BILEAFLET
 Complex
 Open
fluid dynamics
position
Two large lateral valve orifices with a small
narrow central “slitlike” orifice
 Three peak velocities corresponding to three
orifices

Highest velocity in middle orifice
 Local gradients are often substantially higher than
overall valvular pressure

 Closed

position
Two crisscross jets of regurgitation are seen in
plane parallel to the leaflet opening plane
37
OVERALL COMPLICATIONS OF
MECHANICAL VALVES
38
COMPLICATIONS OF MECHANICAL
VALVES
 Thrombus
 Indefinite
anti-coagulation
 Stenosis
 Thrombosis
 Pannus ingrowth
Fibrotic tissue which grows around a newly implanted
prosthetic heart valve.
 Vigorous growth of this healing tissue can freeze or
obstruct a replacement valve.
 May be related, in part, to the design or materials of the
prosthesis, or to the degree of anticoagulation

 Dehiscensce
 Infective
endocarditis
 Hemolysis
39
COMPLICATIONS OF MECHANICAL VALVES
CONTINUED

Mechanical failure
 Ball/disc/cage variance/strut fracture

Heart-valve mismatch

Left ventricular outflow tract obstruction


Valve bed abnormality
 Pseudoaneurysm, valve ring abscess,
fistula, hematoma
Regurgitation
 Central, perivalvular
40
BIOPROSTHETIC VALVES
41
Constructed from either human or animal tissue.
BIOPROSTHETICVALVES

Heterograft (xenograft)

Transfer from animal to human
Longest replaced approximately 10 years
 Typically replaced at 5 years


Auto-graft


Transfer from self to self
Homograft (allograft)

Transfer from one human to another

Last approximately 5 years
42
HETEROGRAFT
43
Transfer from Animal to Human
HETEROGRAFT (XENOGRAFT)
PORCINE VALVES

Limited availability of
heterograft prompted the use of
porcine valves procured from
slaughterhouses

Pig’s aortic valve is placed on
stents, attached to a sewing ring
and glutaraldehyde stabilized

Most common:
Hancock I and II
 Carpentier-Edwards
 Intact (aortic)

Hancock Porcine – Valve Closed
44
NORMAL FUNCTIONING PORCINE
AORTIC PROSTHESIS
•Leaflet opening during systole
resembles that of a normal
native valve.
•Overall appearance is similar
that bioprosthesis
•Occasionally mistaken for
native when historical
information is not available.
• Careful observation
yields an echogenic sewing
ring and struts.
45
NORMAL FUNCTIONING PORCINE
MITRAL PROSTHESIS
46
HETEROGRAFT (XENOGRAFT)
STENTLESS PORCINE VALVE



A low-pressure
glutaraldehyde fixed intact
porcine valve supported by
Dacron cloth
Advantage: No stents
allows larger valve to be
implanted
Two approved valves:
Toronto SPV
 Freestyle Valve
Toronto SPV

47
STENTLESS AORTIC VALVE

Stentless Aortic Valve


48
SAME PATIENT - PSAX
49
HETEROGRAFT (XENOGRAFT)
BOVINE PERICARDIUM

Bovine (cow) pericardium
fashioned into a trileaflet
valve


Mounted on stents and a sewing
ring
Most common brands:
Carpentier-Edwards
 IonescuShiley (Withdrawn from
United States Market)
 Mitroflow

Carpentier Edwards – Valve Closed
50
AUTOGRAFT
51
Transfer from Self to Self
AUTOGRAFT
ROSS PROCEDURE
Excision of the aortic valve
 Placement of the pulmonary valve annulus and
trunk into the aortic position



Reimplantation of the coronary arteries.
Pulmonary side,

a homograft conduit is placed between the right ventricle
and pulmonary artery
52
HOMOGRAFT
53
Transfer from One Human to Another
HOMOGRAFT (ALLOGRAFT)

Rarely used to replace a MV or TV

Aortic Homograft

Harvested from human cadavers shortly after
death, (cryopreseved)
May be sown into the aortic annulus without
stents.
 Customized by the surgeon in the operating room
at the time of implantation.


May be difficult to identify by echocardiography
Aortic root may appear thicker than normal
 Valve failure is usually due to valvular
regurgitation

54
ADVANTAGE OF BIOPROSTHETIC
VALVES
 May
avoid anticoagulation
 Lower pressure gradients
 Central flow dynamics
 Failure usually occurs slowly
 Valve of choice in the tricuspid/pulmonic
position
 Stentless valve may be hemodynamically
superior to stented heterograft
 Increased
effect orifice area
 Lower gradients
 Greater regression of ventricular hypertrophy
55
COMPLICATIONS OF
BIOPROSTHETIC VALVES
 Calcification/degeneration
 Infective

endocarditis
Vegetation, valve ring abscess, fistula
 Dehiscence

(all valve replacements)
Sewing ring around prosthesis becomes
unsecured to surrounding structures
 Inherently
stenotic
 Tissue preserved and fixed with within a
prolypropylene mount attached to a
Dacron sewing ring

Less pliable than native valve tissue.
56
COMPLICATIONS OF BIOPROSTHETIC VALVES – CONTINUED
 Stenosis

Degeneration, thrombotic

Sewing ring may be too small relative to the
flow

In young patients, what was normal as a child
is now too small as an adult

Effective orifice area is significantly smaller
than the area of the sewing ring

Valve assembly (i.e. occluder mechanism) occupies some of
the central space
57
COMPLICATIONS OF BIOPROSTHETIC
VALVES - CONTINUED

Deterioration of tissue valve

Occurs at an accelerated rate



Older patients, especially in those with a risk of
falling,


Younger patients
Patients with end-stage renal disease on hemodialysis.
Tissue valve may be the most appropriate choice.
Tissue valves are less durable than mechanical valves
with a reported failure rate of




25% at 10 years
42% at 12 years
60% at 15 years
58
The failure rate is higher in young patients (less than 35 years
of age) and in chronic renal failure patients
VALVED CONDUITS
59
VALVED CONDUITS
 Used
in congenital heart surgery and
ascending aortic repairs
 When
a new passageway for blood flow and a
valve are needed
 May
be biologic (i.e. homograph) or
artificial (i.e. Gore-Tex or Dacron)
material
 May
incorporate either tissue or a
mechanical valves
 Fluid
dynamics similar to those for a
valve implanted in the native annulus
60
CARPENTIER-EDWARDS BIOPROSTHETIC VALVED
CONDUIT
61
OTHER CONDUITS
62
EVALUATION OF
PROSTHETIC VALVES
BY TRANSTHORACIC
ECHOCARDIOGRAPHY
63
EVALUATION OF PROSTHETIC VALVES BY
TRANSTHORACIC ECHOCARDIOGRAPHY
Confirm stability of the sewing ring
 Determine the specific type of prosthesis
 Confirm the opening and closing motion of the
occluding mechanism



Can be difficult but with careful interrogation the
rapid motion of the leading edge of the disk or ball
generally can be recorded.
Evaluate for gross structural abnormalities such
as vegetations and thrombi
64
TEE EVALUATION OF
PROSTHETIC VALVES
65
EVALUATION BY TEE GENERAL
QUESTIONS THAT SHOULD BE ANSWERED
 Is
there valve dehiscence?
 Is
there evidence of torn/flail leaflets, ball/disc
variance?
 Are there mass lesions?
 Vegetations, thrombi, pannus
 Is
there valve ring abscess / pseudoaneurysm/
fistula?
 How
much volume/leakage volume/ pathological
valvular regurgitation / paravalvular leak is
present?
 Is
there valvular stenosis?
66
TEE EVALUATION OF PROSTHETIC VALVES
 Helpful
in patients who are too unstable to
undergo cardiac catheterizations
 Surface
study is inadequate for diagnosis
 Regurgitation
jets appear larger as compared
to transthoracic
67
Non dynamic
PRESSURE RECOVERY
68
PRESSURE RECOVERY

Downstream pressure after an
obstruction


After flow passes through orifice



Will be lower than the upstream
pressure before
Pressure recovers toward its original
value
Rate and magnitude: variable
depending on valvular geometry
Difference between cardiac
catheterization and
echocardiography pressure gradients
69
ROUTINE
EVALUATION OF
PROSTHETIC
VALVES
70
ROUTINE EVALUATION OF PROSTHETIC VALVES
 Chamber
dimension and function
 Valve type and movement
 Peak flow velocity
 Maximum and mean pressure gradients
 Pressure half time
 Generally
overestimates valve area in
presence of mitral prosthesis
71
ROUTINE EVALUATION OF PROSTHETIC VALVES
Effective orifice area by continuity equation
 Pulmonary artery pressures
 Diastolic filling profile
 Color flow jet length, duration and area, pulmonary
vein (mitral regurgitation)
 Color flow jet or descending thoracic aorta flow (aortic
regurgitation)

72
GENERAL M-MODE/ 2-D/
CARDIAC DOPPLER FINDINGS
POST-PROSTHETIC VALVE
SURGERY
73
POST-PROSTHETIC VALVE SURGERY
14.23 Feigenbaum
74
GENERAL M-MODE/ 2-D/ CARDIAC DOPPLER
FINDINGS POST-PROSTHETIC VALVE SURGERY
Aortic Stenosis
 Left ventricular systolic/diastolic function


Left ventricular hypertrophy


Will be reduced compared to pre-op but a residual peak and
mean gradient will be present due to aortic valve
replacement
If mitral regurgitation was present before surgery,


Should regress
Peak/mean gradient


Should improve is decreased preoperatively
May be decreased in severity post-op
Left ventricular intracavitary systolic gradients

May predict a poor prognosis
75
GENERAL M-MODE/ 2-D/ CARDIAC DOPPLER
FINDINGS POST-PROSTHETIC VALVE SURGERY
Aortic Regurgitation
 Left ventricular dimensions


Should decrease with an improvement of ventricular
systolic function
Peak/mean gradients

Will be increased for prosthetic heart valve compared to
native aortic valve
76
GENERAL M-MODE/ 2-D/ CARDIAC DOPPLER FINDINGS POSTPROSTHETIC VALVE SURGERY
Mitral Stenosis
 May be a slight increase in


Left atrial dimension


Will be reduced compared to pre-op
Mitral valve area


May be left intact
Peak/mean gradients


May be obliterated at surgery
Valve leaflets, chordae tendineae, papillary muscles


May decrease slightly but usually will not normalize
Left atrial appendage


Left ventricular dimensions
Larger than pre-op
Pulmonary artery pressures

May decrease
77
GENERAL M-MODE/ 2-D/ CARDIAC DOPPLER FINDINGS
POST-PROSTHETIC VALVE SURGERY
Mitral Regurgitation
 LV dimension


LA dimension


May be left intact
Decreased compared to pre-op with mitral valve
replacement


Should decrease but will not normalize
Valve leaflets, chordae tendineae, papillary muscles


Should decrease with an improvement in systolic function
Transmitral peak velocity, peak pressure gradient, mean pressure
gradient
Pulmonary artery pressures may decrease
78
NORMAL OR
PHYSIOLOGICAL
REGURGITATION
79
NORMAL OR PHYSIOLOGIC REGURGITATION

Regurgitation occurs in
Virtually all types of mechanical prostheses
 Seating regurgitation or "closure backflow" appears
only briefly



Due to retrograde volume displacement as the valve leaflets
close.
Divided into two types
Closure backflow
 Leakage

80
COMPLICATIONS
81
AORTIC ROOT ABSCESS

Echo-free space is seen posterior to the aortic root
and associated perivalvular regurgitation.
14.27b Feigenbaum
82
14.27 Feigenbaum
PERIVALVULAR LEAK

Example of stentless
aortic prosthetic valve

Mild degree of
perivalvular
regurgitation is seen.
14.28a Feigenbaum
83
OBSTRUCTION

The most common cause of prosthesis
obstruction is the presence of a thrombus.
84
THROMBUS ECHOCARDIOGRAM

Large thrombus

Left atrial aspect of
the mitral prosthesis
14.37 Feigenbaum
85
VEGETATION

Prosthetic valve

Most common site for
attachment of a
vegetation is the sewing
ring.
 Large
vegetation can be
seen in the left atrium

Attached to the sewing
ring of a St. Jude mitral
prosthesis.
14.46 Feigenbaum
86
RING ABSCESS
14.51b Feigenbaum
87
14.51c Feigenbaum
DEHISCENCE
 Dehiscence
of porcine
mitral prosthesis
Excessive motion of the
prosthetic valve was
evident.
 Abnormally
high peak
flow velocity (2.8
cm/sec)

Increased gradient (14
mm Hg)
88
14.52 Feigenbaum
VALVED CONDUITS
89
VALVED CONDUITS
 Part
of repair of some forms of complex
congenital heart disease
 Not
all conduits contain valves and those
that do may use either bioprosthetics or
mechanical prostheses.
 Conduit
itself often has a characteristic
echocardiographic appearance due to the
conduit material and the ribbed design
90
REPAIR


Adult patients with aortic valve pathology are
seldom candidates for valve repair.
Valve replacement is usually necessary for
significant aortic stenosis or regurgitation.
91
MITRAL VALVE REPAIR
92
MITRAL VALVE REPAIR

Repairing rather than replacing


Several advantages and is being performed with increasing
frequency.
Mitral and tricuspid valve pathologies should be
considered for valve repair

Operative mortality associated with repair of these valves
is lower than that associated with their replacement.
93
MITRAL VALVE REPAIR
 Selection
of repair vs. replace is
dependent upon
Etiology, morphology and severity as
well as the status of the left ventricle.
 Replacement for :severe scarring and
deformation by a disease process such as




advanced rheumatic heart disease
advanced lupus
another inflammatory process
94
MITRAL VALVE REPAIR SUCCESS RATE IN PATIENTS WITH
MYXOMATOUS DEGENERATION AND MITRAL VALVE PROLAPSE
 Posterior
 Carries
repair

leaflet prolapse
a greater likelihood of successful
Than anterior or bi-leaflet prolapse
95
http://www.escardio.org/communities/EAE/CasePortal/Pages/Case159.aspx
96
SOME DEGREE OF REGURGITATION
MAY REMAIN AFTER REPAIR

Stable mitral ring in mitral
position

Well preserved leaflet excursion
14.59 Feigenbaum
97
14.60a Feigenbaum
FUTURE OF VALVULAR
REPLACEMENT?
98
99
SAFETY AND EFFICACY STUDY OF THE MEDTRONIC COREVALVE®
SYSTEM IN THE TREATMENT OF SYMPTOMATIC SEVERE AORTIC
STENOSIS IN HIGH RISK AND VERY HIGH RISK SUBJECTS WHO NEED
AORTIC VALVE REPLACEMENT
Clinical Trial for transcatheter aortic valve
implantation (TAVI)
 >1,300 patients
 Subjects have one of two options:

1.
2.
Open heart surgical aortic valve replacement
Transcatheter aortic valve implantation (only available
through the clinical trial)
100
CLINICAL TRIAL FOR TRANSCATHETER AORTIC VALVE IMPLANTATION
(TAVI)
45 Sites Across the US.
 Trial Locations in Michigan

Detroit Medical Center
 Spectrum Health Hospitals
 University of Michigan Health Systems

101
COREVALVES
Inclusion criteria
 Predicted risk of operative mortality ≥15%

Senile degenerative aortic valve stenosis

Mean > 40 mmHg/left velocity >4.0 m/sec





AND
Initial AVA ≤0.8 cm2 (or AVA index ≤0.5 cm2/m2)
Symptomatic; NYHC Functional Class II or greater
Subject informed of the nature of the trial, agrees and has
provided written informed consent as approved by IRB of
the respective clinical site
Subject and treating physician agree that the subject will
return for all post-procedure follow-up visits
102
COREVALVES
Exclusion Criteria








Evidence of an acute myocardial infarction ≤ 30 days before the
index procedure.
Any percutaneous coronary or peripheral interventional procedure
performed within 30 days prior to the index procedure.
Blood dyscrasias as defined: leukopenia (WBC < 1000mm3),
thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding
diathesis or coagulopathy, or hypercoagulable states.
Untreated clinically significant coronary artery disease requiring
revascularization.
Cardiogenic shock manifested by low cardiac output, vasopressor
dependence, or mechanical hemodynamic support.
Need for emergency surgery for any reason.
Severe ventricular dysfunction with left ventricular ejection
fraction (LVEF) < 20% as measured by resting echocardiogram.
Recent (within 6 months) cerebrovascular accident (CVA) or transient
ischemic attack (TIA).
103
COREVALVES
Exclusion Criteria
 End stage renal disease requiring chronic dialysis or
creatinine clearance < 20 cc/min.
 Active Gastrointestinal (GI) bleeding within the past 3
months.
 A known hypersensitivity or contraindication to any of the
following which cannot be adequately pre-medicated:





aspirin
Heparin (HIT/HITTS) and bivalirudin (only for Extreme Risk
patients)
nitinol (titanium or nickel alloy)
ticlopidine and clopidogrel
contrast media
104
COREVALVES
Exclusion Criteria









Ongoing sepsis, including active endocarditis.
Subject refuses a blood transfusion.
Life expectancy < 12 months due to associated non-cardiac co-morbid
conditions.
Other medical, social, or psychological conditions that in the opinion of an
Investigator precludes the subject from appropriate consent.
Severe dementia (resulting in either inability to provide informed consent
for the trial/procedure, prevents independent lifestyle outside of a chronic
care facility, or will fundamentally complicate rehabilitation from the
procedure or compliance with follow-up visits).
Currently participating in an investigational drug or another device trial.
Symptomatic carotid or vertebral artery disease.
Additional Exclusion for High Risk Surgical only: Subject has been offered
surgical aortic valve replacement but declined.
Anatomical
105
COREVALVES (TAVI)
Exclusion Criteria
 Native aortic annulus size < 20 mm or > 29 mm per the baseline
diagnostic imaging.

Pre-existing prosthetic heart valve any position.

Mixed aortic valve disease (aortic stenosis and aortic regurgitation
with predominant aortic regurgitation (3-4+).

Moderate to severe (3-4+) or severe (4+) mitral or severe (4+)
tricuspid regurgitation.

Moderate to severe mitral stenosis.

Hypertrophic obstructive cardiomyopathy.

Echocardiographic evidence of intracardiac mass, thrombus or
vegetation.

Severe basal septal hypertrophy with an outflow gradient.

Aortic root angulation (angle between plane of aortic valve annulus and horizontal
plane/vertebrae) > 70° (for femoral and left subclavian/axillary access) and > 30° (for 106
right subclavian/axillary access).
COREVALVES
Ascending aorta diameter > 43 mm unless the
aortic annulus is 20-23 mm in which case the
ascending aorta diameter > 40 mm.
 Congenital bicuspid or unicuspid valve verified
by echocardiography.
 Sinus of valsalva anatomy that would prevent
adequate coronary perfusion.
 Vascular
 Transarterial access not able to accommodate an
18Fr sheath.

107
SOURCES
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

CoreValve U.S. Pivotal Trial. Medtronic. [Online] 2010. [Cited:
February 20, 2012.]
http://www.medtronic.com/corevalve/ous/system.htm.
Feigenbaum H, Armstrong W. (2004). Echocardiography. (6th
Edition). Indianapolis. Lippincott Williams & Wilkins.
Goldstein S., Harry M., Carney D., Dempsey A., Ehler D.,
Geiser E., Gillam L., Kraft C., Rigling R., McCallister B., Sisk
E., Waggoner A., Witt S., Gresser C.. (2005). Outline of
Sonographer Core Curriculum in Echocardiography.
Kardon, Eric. Prosthetic Heart Valves. Medscape Reference.
[Online] February 08, 2010. [Cited: February 20, 2012.]
http://emedicine.medscape.com/article/780702-overview.

Otto C. (2004). Textbook of Clinical Echocardiography. (3rd
Edition). Elsevier & Saunders.

Reynolds T. (2000). The Echocardiographer's Pocket
Reference. (2nd Edition). Arizona. Arizona Heart Institute.
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