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Amanda Mairs PA-C, MPAS
Valve Clinic Coordinator
Regions Heart Center
TAVR
Current Strategies for Treatment of
Aortic Stenosis
•Review of aortic stenosis
•Current treatment options
•TAVR procedure, options and risks
•TAVR Candidates
•Outcomes
Symptoms of Aortic Stenosis
•Exertional dyspnea
•Angina
•Pre-syncope or syncope
•Palpitations
•Rapid or irregular heartbeat
•Congestive Heart Failure
Images courtesy of Renu Virmani MD at the CVPath Institute
Echocardiographic Guidelines for assessing Severe
Aortic Stenosis6
*
*Doppler-Echocardiographic measurements

According to the 2014 ACC/AHA guidelines, severe aortic stenosis is defined as:


Aortic valve area (AVA) less than 1.0 cm2
Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s
2014 AHA/ACC Valvular Heart Disease
Guidelines
*
 Symptomatic severe high-gradient AS
 Symptomatic severe low-flow/low gradient AS with
reduced LVEF
 AVA <1.0 cm2 with resting aortic Vmax <4 m/s or mean DP <40 mm Hg
 Dobutamine stress echocardiography shows AVA <1.0 cm2 with
Vmax >/= 4 m/s at any flow rate
 Symptomatic severe low-gradient AS with normal LVEF or
paradoxical low-flow severe AS
 AVA <1.0 cm2 with aortic Vmax <4 m/s or mean DP <40 mm Hg
 Indexed AVA <0.6 cm2/m2 and stroke volume index <35 mL/m2
 Measured when patient is normotensive (systolic BP <140 mm Hg)
Aortic Stenosis Progression

Survival after onset of severe symptoms is 50% at 2 years1

Surgical intervention for severe aortic stenosis should be considered without
delay once symptoms occur 1
Prevalence of untreated Severe Aortic Stenosis

Many patients with Severe Aortic Stenosis are not treated with an AVR9-15
Treatment Recommendations
 2014 AHA/ACC guidelines recommend
consideration of valve replacement (via Surgical
Aortic Valve Replacement or Transcatheter Aortic
Valve Replacement [TAVR/TAVI]) in patients with
severe aortic stenosis AND:
 Symptoms (class I)
 Asymptomatic with LVEF < 50% (class I)
 Abnormal Exercise Treadmill Test (class IIa)
 Medical Management/BAV for patients in which
valve replacement is felt to be futile/ extreme risk
What is TAVR?
Hybrid Operating Room
What could possibly go wrong?
Catastrophic complications: ~1% occurrence
Vessel perforation
Aortic annulus rupture
Coronary occlusion
LV perforation
Valve embolization
Cardiac arrest
Peripheral embolization
TAVR: not yet perfect
 Paravalvular Leak
 Permanent Pacemaker Implantation
 Vascular Complications
 Stroke
Edwards Sapien 3
 Balloon-Expandable
Valve
 Bovine Pericardium
 20, 23, 26, 29 mm
valves
 14-16 Fr sheaths access
for 5.5-6.0 mm luminal
diameters
No. 2 pencil = hexagonal
height of 6mm, outer
diameter 7mm ~18 Fr
Transcatheter Heart Valve Deployment TF
Medtronic CoreValve Evolut
 Self-expanding valve,
Nitinol frame and porcine
tissue valves
 23, 26, 29, 31 mm valves
 Re-capturable valve
 14 French sheath, 5.0 mm
minimal luminal diameter
Access Options
Alternative Access Options
 Some patients may
During the transapical
approach, the
transcatheter heart valve
is delivered through the
apex of the heart by
making a small incision
between the ribs
 For these patients,
During the transaortic
approach, the Edwards
SAPIEN transcatheter
heart valve is delivered
through an incision in the
front of the chest
not have adequate
vascular access to
accommodate the
sheath used during
transfemoral
procedures
alternative access
approaches are
available, such as
transapical and
transaortic
Advances in Technology
 More patients eligible for TAVR valves and
transfemoral access
 Fewer vascular/bleeding complications
 More percutaneous approaches
 Less invasive procedures:
 Conscious sedation, no Intra-op TEE, shorter duration
 Fewer invasive lines (central lines, foleys)
Post-procedure Care
 81 mg ASA lifelong
 75mg Plavix for 3-6 months (unless
contraindication)
 POD 1 Echo- valve position and function
 LV/RV function, mitral valve function
Candidates for TAVR
 Patients with severe
symptomatic calcified
native aortic valve stenosis
found to be either inoperable
or at high risk for surgical
aortic valve replacement.

Clinical trials including Intermediate
Risk patients are currently underway
in the US, approved for use in Europe
 Re-do procedures (“valve-in-
valve”) with previous surgical
bioprosthetic valve
Characteristics of a TAVR Patient
TAVR patients may present with some of the following:
Severe, symptomatic native aortic valve stenosis
Old age
History of stroke/CVA
Frailty
History of syncope
Reduced EF
Heavily calcified aorta
Prior CABG
Prior chest radiation
History of AFib
Prior open chest surgery
Fatigue, slow gait
Peripheral vascular disease
History of CAD
History of COPD
History of renal insufficiency
Diabetes and hypertension
Our TAVR Patients
*Pt photo consent obtained
TAVR Evaluation process
Confirm the
patient is
diagnosed with
severe
symptomatic
native aortic
stenosis
Confirm the
patient has been
evaluated by two
cardiac
surgeons and
meets the
indication for
TAVR
Evaluate the
aortic valvular
complex using
echocardiography
Evaluate the
aortic valvular
complex and
peripheral
vasculature
using CT
Evaluate the
aortic valvular
complex and
peripheral
vasculature
using
catheterization
Determine
access route
for
transcatheter
aortic valve
replacement
Frailty
 ADL’s
 Grip Strength
Frailty Index
 Serum Albumin
 5 meter walk test
How frail is too frail?
Regions TAVR Program
Valve Clinic Patients: where do they end up?
Valve Clinic 2014-15
29
65
Total Patients: 189
58
35%
30%
15
14%
Surgical AVR
TAVR
Med Mgmt
/Palliative
BAV
19
3
12%
12%
Referred
On Hold
Under Eval
Regions TAVR Program/Patient Demographics
 Patients:
 Median age: 85 years old
 Median STS score: 9.5%
 51.7% female
 48.3% male
 Program
 Program started in April 2012
 Performed 95 cases to date
 3-5 cases per month; 35 in 2015
 Average length of stay (TF): 4.0 days
Regions Outcomes
TAVR Outcomes
National
Regions 2014 Q2
84 85
24
16.5
7.1 9.5
7
0
Median Age Median STS%
4.1 3.1
30 day
1 year
Stroke (%)
mortality (%) mortality* (%)
Aortic Valve Replacement Improves Survival
16
Survival, %
Patient Survival
100
90
80
70
60
50
40
30
20
10
0
AVR,
noSymptoms
Sx
AVR, No
AVR,
Sx
AVR, Symptoms
No AVR,
Symptoms
No
AVR,Nono
Sx
No AVR,
No
AVR,Symptoms
Sx
0
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15
Years

Study data demonstrate that early and late outcomes were similarly good in both
symptomatic and asymptomatic patients

Among asymptomatic patients with Severe Aortic Stenosis, omission of surgical
treatment was the most important risk factor for late mortality
Improved Survival
THE PARTNER TRIAL COHORT B
Reduced Symptoms
Also reducing repeat hospitalizations
THE PARTNER TRIAL COHORT B
CoreValve Pivotal Trial
All-cause mortality at 1 year came in at 14.2% with Medtronic's device versus
19.1% with surgical valve replacement, meeting criteria both for non-inferiority
and superiority (P<0.001 and P=0.04)
Major adverse cardiovascular and cerebrovascular events at 1 year were
reduced compared with surgery in an exploratory analysis (20.4% versus 27.3%,
P=0.03).
Regions Hospital Heart Center Contact information:
Regions Direct:
651-254-2000
Cardiology MD on call- TAVR
RHC Scheduling Line: 651-254-4887
“Valve Clinic/TAVR Consult”
Amanda Mairs, PA-C, TAVR Coordinator
Pager: 651-629-0711
Email: [email protected]
References
1.
Otto CM. Timing of aortic valve surgery. Heart. 2000;84:211-21.
2.
Census.gov – 2010 US Census Report.
3.
Ramaraj R, Sorrell VL. Degenerative aortic stenosis. Br Med J 2008;336: 550–5.
4.
Stewart BF, Siscovick D, Lind BK, et al. Clinical factors associated with calcific aortic valve disease. Cardiovascular Health Study. J Am Coll Cardiol. 1997;29:630-634.
5.
Mayo Clinic Staff; September 22, 2011: www.mayoclinic.com - http://www.mayoclinic.com/health/aortic-valve-stenosis/DS00418/DSECTION=symptoms.
6.
ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease: A Report of the ACC/AHA Task Force on Practice Guidelines (Writing
Committee to Revise the 1998 Guidelines for the Management of Patients With Valvular Heart Disease) DOI: 10.1161/CIRCULATIONAHA.108.190748 Circulation
published online Sep 26, 2008.
7.
Lester SJ, Heilbron B, Dodek A, Gin K, Jue J. The Natural History And Rate Of Progression Of Aortic Stenosis CHEST 1998;113(4):1109-1114.
8.
National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets.
http://seer.cancer.gov/statfacts/. Accessed November 16, 2010.
9.
Bouma BJ, Van Den Brink RB, Van Der Meulen JH, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences.
Heart. 1999;82:143-148.
10. Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged
follow-up. Circulation. 2005;111:3290-3295.
11. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis. 2006;15:312-321
12. Varadarajan P, Kapoor N, Banscal RC, Pai RG. Clinical profile and natural history of 453 nonsurgically managed patients with severe aortic stenosis.
Ann Thorac Surg. 2006;82:2111-2115.
13. Jan F, Andreev M, Mori N, Janosik B, Sagar K. Unoperated patients with severe symptomatic aortic stenosis. Circulation. 2009;120;S753.
14. Bach DS, Siao D, Girard SE, et al. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the
potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009;2:533-539.
(Continues
nextvalve
page)replacement in patients with severe aortic stenosis and
15. Freed BH, Sugeng L, Furlong K, et al. Reasons for nonadherence to guidelines
foron
aortic
potential solutions. Am J Cardiol. 2010;105:1339-1342.
References (Continued)
(Continued from previous page)
16. Brown ML, Pellikka PA, Schaff HV, et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac
Cardiovasc Surg. 2008;2:308-315.
17. Leon M, Smith C, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. New England Journal of
Medicine 2010 October 21;363(17):1597-1607.
18. Smith, C. et. al. Transcatheter versus Surgical Aortic-Valve eplacement in High-Risk Patients. N Engl J Med. 2011;364(23): 2187-2198
19. Dumesnil et al, Paradoxical low flow and/or low gradient severe aortic stenosis despite preserved left ventricular ejection fraction: implications for diagnosis and
treatment European Heart Journal 2010; 31, 281-289.
20. Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A: A global clinical measure of fitness and frailty in elderly people.
CMAJ 2005, 173:489-495.
21. Columbia Frailty Index, adapted from Fried, J Gerontol Med Sci 2001.