Presentation by Dr Chuang Hsuan-Hung Cardiologist, Heart Failure Intensivist Medical Director Asian Heart & Vascular Centre www.ahvc.com.sg

1. Surgical orTranscatheterValve Surgery:
What your patients need to know in a
litigious society
Dr Chuang Hsuan Hung

2. Scope
• Pathophysiology of aortic stenosis & risks
• Types of intervention & potential complications
• Current guideline, limitation & timing
• Future strategies

3. • In his 1958 Nathanson lecture, Dr PaulWood argued
prophetically that “aortic stenosis is a simple
mechanical fault which, if severe enough, imposes a
heavy burden on the left ventricle and sooner or
later overcomes it”
• The burden of As on the left ventricle remains true
today, but what has changed is that AS
management is no longer simple

5. BUT CHIEF JUSTICE MENON SAIDTHAT “A
DOCTOR IS NOT UNDER A DUTYTO
CONVEYTO HIS PATIENT EVERY
CONCEIVABLE RISK”.
REALLY?

6. Number of deaths per year due to heart valve disease

7. Aortic Sclerosis  Aortic Stenosis
 Aortic sclerosis: ~25% of
population over 65-74 yrs;
48% of people over age of
84 yrs
 AV sclerosis is an indicator
of increased CV risk

8. Progression of Aortic Sclerosis to Stenosis
400 patients, leaflet sclerosis and initial velocity Vmax <2 m/s
Vmax >3.0: mild ; 3.1-3.9: moderate ; >4.0: severe
Faggiano et al. Am J Cardiol 2003;91:99; Cosmo et al. Arch Intern Med 2002
AV sclerosis progresses to AV stenosis in 9% over 5 yrs
Average time interval to severe stenosis is 8 years

9. Prevalence of Aortic Stenosis
16.5 Million People in US
Over the Age of 652
7%
Percentage
Diagnosed with
Aortic Stenosis
 Aortic stenosis is
estimated to be
prevalent in up to 7%
of the population over
the age of 651
 It is more likely to
affect men than
women; 80% of adults
with symptomatic
aortic stenosis are
male3
Eveborn et al. The evolving epidemiology of valvular aortic stenosis. Heart 2013
Stewart et al. Clinical Factors Associated With Calcific Aortic Valve Disease. JACC 1997

10. What Causes Aortic Stenosis in Adults?
Aortic stenosis in patients
over the age of 65 is
usually caused by calcific
(calcium) deposits
associated with aging
Age-Related Calcific
Aortic Stenosis
Congenital
Abnormality
In some cases adults may
develop aortic stenosis
resulting from a congenital
abnormality
More Common
Less Common
Rheumatic Fever
Adults who have had
rheumatic fever may also
be at risk for aortic stenosis

11. What Causes Aortic Stenosis in Adults?
The cause of severe aortic stenosis in patients <50 yrs is
almost always congenital!!!

12. *
Echocardiographic Guidelines are the Gold Standard
in Assessing Severe Aortic Stenosis
• 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
• Beware of the not-so-classic aortic stenosis
– Low flow, low gradient severe AS
– Paradoxical low flow, low gradient severe AS

13. Disease Stages in Aortic Stenosis

14. AS is life-threatening & rapidly progressive
- Survival after onset of symptoms is
50% at 2 years and 20% at 5 years1
- Surgical intervention for severe aortic
stenosis should be performed promptly
once even minor symptoms occur1

15. Mortality of Nonsurgically treated patients
with severe aortic stenosis

16. 0
10
20
30
40
50
60
70
80
90
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Survival%
AVR, no Sx
AVR, Sx
No AVR, no Sx
No AVR, Sx
 Study data demonstrate that early and late outcomes were similarly good in both
symptomatic and asymptomatic patients
 It is important to note that among asymptomatic patients with SAS, omission of
surgical treatment was the most important risk factor for late mortality
Aortic Valve Replacement Greatly Improves Survival
Patient Survival AVR, No Symptoms
AVR, Symptoms
No AVR, No Symptoms
No AVR, Symptoms
Years
Morgan L. Brown et al. The benefitsof early valve replacement in asymptomatic patients with severe aortic stenosis. JThorac CardiovascSurg. 2008;135(2):308-315.

17. Source: Robert O. Bonow et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice
Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Valvular Heart Disease). JACC. 2006;e17-e26.
Traditional ACC/AHA Indicators for AVR

18. Butany Jand Collins MJ.JClin Pathol2005;58:113–124.
.
Complications of SAVR

19. • Studies show at least 40% of patients with severe AS are not treated with an AVR9-15
Low Percentage of AorticValve Surgery
Aortic Valve Replacement
No Aortic Valve Replacement

20. Surgery versus MedicalTherapy
 OPERATIVE RISK OF AVR
 SUDDEN DEATH RISK NOTTOTALLY ABOLISHED
 PROSTHETICVALVE COMPLICATIONS
 Even if surgical mortality can be minimized, the combined
risk of valve replacement and the late complications of a
prosthetic valve exceed the possibility of preventing sudden
death in a truly asymptomatic patient

21. • Successful BAV in 80.8%, In-hospital major comp 6.8%, Death 2.5%
• 56% mortality after single BAV at 1 year
• Patients bridged to SAVR had the best outcome

22. Most would agree
 It may be used for patients who have symptomatic AS in need of
emergent noncardiac surgery.The hemodynamic improvement of BAV is
immediate, and it may decrease the risk of general anesthesia. In these
situations, the BAV should be reserved for patients with severe AS who
have the potential for hemodynamic compromise.
 It may be used to determine the contributing role ofAS to dyspnea in
patients with concomitant severe lung disease and to gauge potential
improvement and risks of undergoing SAVR orTAVR.
 It may be used to assess the myocardial contractile reserve in patients
with a low pressure gradient or low ejection fraction in whom associated
cardiomyopathy is questionable. Patients with no demonstrated
contractile reserve can have a perioperative mortality rate as high as
62%.The indication for SAVR orTAVR can be clarified 2 to 3 weeks after
BAV if the left ventricular ejection markedly improves.

23. Evolution ofAS surgery
• The recommendations for choice of intervention for AS take into consideration the
surgical risk, patient frailty, comorbid conditions, and patient preferences and values.
• Concomitant severe coronary artery disease may also affect the optimal intervention
because severe multivessel coronary disease may best be served by surgical AVR
and coronary artery bypass graft surgery (CABG).

24. SUPPORTING EVIDENCE

25. Patients at Extreme Surgical Risk
Foundational trials tested new TAVR therapy in patients without
the option for a surgical aortic valve replacement
CoreValve, N=489, STS 10.3% SAPIEN, N=179, STS 11.2%
US CoreValve Pivotal Trial PARTNER 1B

26. • Cohort B of PARTNERS randomized to TAVR had lower rates of all-cause mortality
(30.7% vs. 50.7%, P < .001), cardiovascular mortality (19.6% vs. 41.9%,P < .001), repeat
hospitalization (22.3% vs. 44.1%, P< .001), and the composite end point of death or
repeat hospitalization (42.5% vs.71.6%, P < .001).
Patients at Extreme Surgical Risk

27. Edwards SAPIENTHV Improved Cardiac Function and
Heart Failure Symptoms
THE PARTNERTRIAL COHORT B
Dramatic reduction in mean gradient in the TAVR arm of Cohort B was sustained
out to 2 years.
Majority of TAVR patients were alive at 12 months and now mildly symptomatic or
asymptomatic in class II or I, respectively. (initially in NYHA class III or IV) , with
improvement was observed as early as 30 days (P < .0001)
Majority of patients in the standard therapy arm didn’t fare as well

28. Complications
THE PARTNERTRIAL COHORT B
The 3-year mortality rate in the TAVR and standard therapy groups was 54.1%
and 80.9%, respectively (P<0.001)
In survivors, there was significant improvement in New York Heart Association
functional class sustained at 3 years.

29. Patients at High Surgical Risk
Trials randomizing high risk patients to either TAVR or SAVR
soon followed
US CoreValve Pivotal Trial PARTNER 1A
SAPIEN, N=348, STS 11.8%
vs.
SAVR, N=351, STS 11.7%
CoreValve, N=390, STS 7.3% vs.
SAVR, N=357, STS 7.5%

30. • All-cause mortality rate at 30 days was slightly lower with TAVR than SAVR (3.4% vs.
6.5%, P = .07) but was similar at 1 year (24.2% vs. 26.8%), 2 years (33.9% vs. 35%), and
3 years (44.2% vs. 44.8%).
• Major strokes were not significantly different between TAVR and SAVR at 30 days (3.8%
vs. 2.1%, P = .2) or at 1 year (5.1% vs. 2.4%, P = .07).
• PARTNER showed that ~35% of patients survived to 5 years, regardless of treatment
PARTNER 1A
5-Year Follow-Up Presented at ACC 2015
1Mack, et al., presented at ACC 2015

31. • The CoreValve Pivotal Trial was the first to show a survival advantage with TAVR
compared to SAVR, with separation of the all-cause mortality curves maintained to 3 yrs
• All-cause mortality at 1 year for TAVR compared to SAVR was 14.2% vs 19.1% for
superiority of P = .04. The 2-year all-cause mortality was 22.2% for TAVR vs 28.6% for
SAVR for continued statistical superiority
• TAVR also statistically superior for stroke (3 years were 4.3% vs 8.3%), major adverse
cardiovascular and cerebrovascular events (MACCE) and flow hemodynamics to 3 years
CoreValve US PivotalTrial
3-Year Follow-Up Presented at ACC 2016
1Deeb, et al., J Am Coll Cardiol 2016 Mar 22

32. Patients at Intermediate Surgical Risk
Randomized trial data comparing TAVR to SAVR in lower-
risk patients recently became available
SAPIEN XT and SAPIEN 3 CoreValve

33. • The PARTNER 2A Trial showed that TAVR with SAPIEN XT was non-inferior to surgery
for the primary endpoint of all-cause mortality or disabling stroke at 2 years 19.3% vs
21.1%
• This study also generated convincing evidence that transfemoral TAVR provides an
outcome advantage to intermediate risk patients (16.3% vs 20%)
• In the as-treated population, TF TAVR significantly reduced all-cause mortality or
disabling stroke vs. surgery (p = 0.04)
Patients at Intermediate Surgical Risk
PARTNER 2A | SAPEIN XT
1Smith, et al., presented at ACC 2016
Renal failure, major bleeding, and new or worsening atrial fibrillation was more common in the surgery group,
whereas PVL was more common in the TAVR group but less so than it was in the original PARTNER A and
CoreValve trials

34. Primary outcome of all-cause mortality and disabling stroke was similar at an
estimated 12.6 percent and 14.0 percent in the TAVR and SAVR arms
Patients at Intermediate Surgical Risk
SURTAVI | The CoreValve Platform
Reardon MJ. Et al. N Engl J Med 2017
•Major vascular complications more common with TAVR (6.0%) vs SAVR (1.1%) at 30 days
•Higher pacemaker implantation in TAVR group (25.9%) vs SAVR (6.6%) at 30 days

36. ALWAYS BE PREPARED TO CHANGEYOUR MIND!
EVEN CONSIDER IT A SIGN OF INTELLIGENCE …
2019:
Low risk
17

37. Patients at Low Surgical Risk
Medtronic Low Risk PARTNER 3
Primary Endpoint Death or major stroke at 2 years
Death, all stroke, or re-hospitalization
(valve-related or procedure-related
and including heart failure) at 1 year
Patients
Symptomatic, severe AS and a Heart
Team predicted risk of 30-day
mortality < 3%
Symptomatic, severe AS and Heart
Team assessment of low operative risk
and STS < 4%
Study Design
• Multi-center, prospective,
randomized
• 1:1 randomization to eitherTAVR or
SAVR
• Multi-center, prospective,
randomized
• 1:1 randomization to eitherTAVR or
SAVR
Devices
Investigational TAVR Arm
• Evolut R
Control Arm
• Any commercially available
bioprosthesis
Investigational TAVR Arm
• SAPIEN 3, transfemoral only
Control Arm
• Any commercially available
bioprosthesis

38. Patients at Low Surgical Risk
Key Exclusion Criteria
Medtronic Low Risk PARTNER 3
• Bicuspid aortic valve • Bicuspid aortic valve
• Multivessel CAD
(Syntax >22, unprotected left main)
• Complex CAD requiring revascularization
(Syntax >32, unprotected left main)
• MI within 30 days • MI within 30 days, stroke/TIA within 90 days
• Severe MR orTR amenable to surgery • Severe AR or MR
• Moderate or severe mitral stenosis • LVEF <30%
• Prohibitive LVOT calcification • Unsuitable iliofemoral vessels forTF
• Hemodynamic or respiratory instability
requiring inotropic support or mechanical
ventilation within 30 days
• CKD – eGFR <30 mL/min
• Significant frailty (objective measurements)
• Severe lung disease or home O2

39. Though the study was likely under-powered, NOTION showed all-cause mortality with TAVR
with CoreValve to be non-inferior to SAVR in patients at lower surgical risk
Patients at Low Surgical Risk
NOTION | The CoreValve Platform
1Sondergaard, presented at EuroPCR 2015
• TAVI group showed a strong favorable trend in terms of the primary composite
endpoint comprising all-cause mortality, MI, or stroke (not statistically significant
because of the relatively small study size
• At 2 years’ follow-up, the TAVI group had significantly larger valve orifice areas
and lower gradients, lower rates of life-threatening bleeding, cardiogenic stroke,
and severe kidney injury than did the SAVR group.
• Moderate aortic regurgitation at 2 years in the TAVI arm of NOTION was 15.4%
• 41% of the TAVI group in NOTION had a pacemaker at 2 years

40. Patients at Low Surgical Risk
PARTNER 3 | Balloon-expandable SAPIEN 3
N Engl J Med 2019; 380:1695-1705
Rate of the primary composite end point at 1 year was significantly lower in the TAVR group
than in the surgery group (8.5% vs. 15.1%)
For the primary endpoint components with TAVR vs. surgery found mortality rates of 1.0%
vs. 2.5%, stroke rates of 1.2% vs. 3.1%, and rehospitalization rates of 7.3% vs. 11.0%

41. Patients at Low Surgical Risk
Medtronic TAVR RCT in Low Risk Patients
N Engl J Med 2019; 380:1706-1715
• For the primary endpoint components with TAVR vs. surgery found mortality rates
of 1.0 percent vs. 2.5 percent, stroke rates of 1.2 percent vs. 3.1 percent, and
rehospitalization rates of 7.3 percent vs. 11.0 percent.
• Atrial fibrillation was higher in the SAVR group.
• Permanent pacemaker was higher with TAVR (17.4% vs 6.1%) as well as
paravalvular regurgitation. However, the mean gradient was lower in the TAVR.
5.3%
6.7%

42. WE REMAIN COGNIZANTTHAT CERTAIN
TECHNICAL CHALLENGES NEEDTO BE
ADDRESSED

43. SpecificTechnicalConsiderations
Strokes
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol Intv 2015;8:1797-806; 3Smith, et al., N Engl J Med 2011;364:2187-98; 4Leon, et al., N Engl J
Med 2016;374:1609-20; 5Popma, et al., J Am Coll Cardiol 2014;63:1972-81; 6Adams, et al., N Engl J Med 2014;370:1790-8;;
Weighted average (n=8,987)
4.2%
The rate of all stroke is generally less than 4% with the new valves, a reduction
relative to stroke rates achieved with the foundation devices

44. SpecificTechnicalConsiderations
New Permanent Pacemaker Implantation
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol Intv 2015;8:1797-806; 3Smith, et al., N Engl J Med 2011;364:2187-98; 4Leon, et al., N Engl J
Med 2016;374:1609-20; 5Popma, et al., J Am Coll Cardiol 2014;63:1972-81; 6Adams, et al., N Engl J Med 2014;370:1790-8;;
3.4%
5.9%
3.8%
6.8%
8.5%
21.6%
19.8%
0%
10%
20%
30%
Extreme Risk
P 1B
N=179
Extreme Risk
P 2B
N=276
High Risk
P 1A
N=348
Extreme Risk
P 2B
N=284
Intermediate
Risk
P 2A
N=1,011
Extreme Risk
US Pivotal
N=489
High Risk
US Pivotal
N=390
SAPIEN SAPIEN XT CoreValve
30-DayPermanentPacemaker
Weighted average (n=8,987)
11.3%

45. SpecificTechnical Considerations
Conundrum of PPM Implantation afterTAVI
Circ Cardiovasc Interv. 2017;10:e005514

46. SpecificTechnicalConsiderations
Vascular Complications
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol Intv 2015;8:1797-806; 3Smith, et al., N Engl J Med 2011;364:2187-98; 4Leon, et al., N Engl J
Med 2016;374:1609-20; 5Popma, et al., J Am Coll Cardiol 2014;63:1972-81; 6Adams, et al., N Engl J Med 2014;370:1790-8;;
16.2%
15.2%
11.0%
9.5%
7.9% 8.2%
5.9%
0%
5%
10%
15%
20%
Extreme Risk
P 1B
N=179
Extreme Risk
P 2B
N=276
High Risk
P 1A
N=348
Extreme Risk
P 2B
N=284
Intermediate
Risk
P 2A
N=1,011
Extreme Risk
US Pivotal
N=489
High Risk
US Pivotal
N=390
SAPIEN SAPIEN XT CoreValve
30-DayMajorVascularComplications
*Definitions vary across studies
Weighted average (n=8987)
7.7%

47. SpecificTechnicalConsiderations
Patient Prosthesis Mismatch

48. Incidence & Impact on Mortality of PPM following AVR

49. SpecificTechnicalConsiderations
Patient Prosthesis MismatchPercentageofpatients
Patient Prosthesis Mismatch was defined as severe if the effective
orifice area (EOA) index was ≤0.65 cm2/m2.
1 mo 6 mo 1 y 2 y
Corevalve US Clinical Trials
More SAVR Patients with Severe PPM at all Time Points (All P< 0.0001)

50. SpecificTechnicalConsiderations
Patient Prosthesis Mismatch
Zorn et al J Thorac Cardiovasc Surg 2015; epub before print
Severe PPM is associated with a higher mortality rate at one year

51. SpecificTechnicalConsiderations
Paravalvular Leak
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol Intv 2015;8:1797-806; 3Smith, et al., N Engl J Med 2011;364:2187-98; 4Leon, et al., N Engl J
Med 2016;374:1609-20; 5Popma, et al., J Am Coll Cardiol 2014;63:1972-81; 6Adams, et al., N Engl J Med 2014;370:1790-8;;
68.0%
43.0% 41.0% 37.9%
22.5%
41.5%
35.7%
12.0%
17.1%
12.0% 24.2%
3.7%
11.4%
9.0%
0%
20%
40%
60%
80%
100%
Extreme Risk
P 1B
N=153
Extreme Risk
P 2B
N=225
High Risk
P 1A
N=287
Extreme Risk
P 2B
N=236
Intermediate
Risk
P 2A
N=872
Extreme Risk
US Pivotal
N=418
High Risk
US Pivotal
N=356
SAPIEN SAPIEN XT CoreValve
30-DayParavalvularLeak
Weighted average (n=5,127)
Mild 34% / Moderate-Severe 10%

52. StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis
SVD is not usual (≤15%) during the first decade post-SAVR, but its incidence
progressively increases.
Key determinant factors: Patient related, CV risk/comorbidities, Valve related

53. StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis

54. Structural Valve
Deterioration (SVD)
A valve-centered
endpoint
Bioprosthetic Valve
Failure (BVF)
A patient-centered
endpoint
Endpoints for Durability Studies of TAVI
or SAVR Bioprosthesis
Reoperation does not necessarily imply SVD and vice versa!

55. BioprostheticValve Dysfunction
EAPCI/ESC/EACTS Standardized Definitions

56. MECHANISMS OF VALVEFAILURE
AdaptedfromSalaunE,etal.Heart.2018;104:1323-1332
Patient RelatedFactors
Dyslipidemia |Diabetes |Hypertension
Metabolicsyndrome
Phospho-calcicdysregulation
Immunereaction
Prosthesis RelatedFactors
Absence of anti-mineralizationtreatment
Flaws in the bioprosthesisdesign
Severeprosthesis-patientmismatch
Small prosthesissize
Structural ValveDeterioration
Leafletcalcification
Leaflettear
Increased leaflet
mechanicalstress
Abnormaltrans-
valvular flow patterns
Inflammation
Non-Structural ValveDysfunction
Paravalvular
leakage
TAVIspecificfactors
▶Leaflet injury(crimping,
loading, dilatation)
▶Abnormal trans-and/orpara-
valvular flowpatterns
▶Non-circular,irregular,
incomplete stentdeployment
Endocarditis
Leaflet
thrombosis
Mechanisms of Valve Failure

57. AdaptedfromSalaunE,etal.Heart.2018;104:1323-1332 CapodannoD,etal.EurHeartJ. 2017;38:3382-3390
Structural ValveDeterioration
Leafletcalcification
Leaflettear
Non-Structural Valve Dysfunction
Paravalvular
leakage
Endocarditis
Leaflet
thrombosis
Hemodynamic ValveDeterioration
Bioprosthetic ValveFailure Normal bioprosthetic valve
Pharmacotherapy
Meantransprosthetic gradient
≥20-<40 mmHgor≥10-<20 mmHg
changefrom baseline
Moderate intra-prosthetic aortic
regurgitation, new or worsening
(>1+/4+)from baseline
Meantransprosthetic gradient
≥40 mmHgor≥20 mmHgchange or
severeintra-prosthetic aorticregurgitation
Autopsyfindings likelyrelated to the cause
of death, valve-related death, repeat
intervention
Stage1
Morphological
SVD andNSVD
Stage2
ModerateHVD
Stage3
SevereHVD
Consequences of Bioprosthetic Degeneration
Subclinical changes on echocardiography should probably alert clinicians about possible
structural changes within the bioprosthesis warranting several considerations :
1) Additional imaging tests to confirm/dismiss a more relevant SVD;
2) Closer follow-up considering that the time period between subclinical and clinically

58. StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis
Rodriguez-Gabella T et al. J Am Coll Cardiol 2018;71(13):1401-12
672 SAVR, (209)
2002-2004
Older age, left ventricular dysfunction, atrial fibrillation, chronic obstructive pulmonary disease, greater
body mass index, and diabetes mellitus were associated with an increased mortality risk.
Clinically relevant SVD occurred in 6.6% of patients; 30.1% of patients had subclinical SVD.

59. Years of Follow-Up on Commercially AvailableValves &
Meta-Analysis ofTranscatheterValve Failure
Accelerated wear testing
has demonstrated in vitro
durability of longer than 10
years, but midterm
structural valve failure has
not been rare, although
clinical follow-up remains
limited beyond 3 to 5
years.
Whether such durability is
sufficient for younger
patients with the potential
for longevity remains to be
determined.

60. Limited data onTAVR durability, but
TAVR had significantly better valve performance over SAVR
PARTNER 5-Year Echo Prosthetic Performance
(A) Aortic valve area. (B) Mean transvalvular gradient.
5-year results of the PARTNER-1 showed no evidence
of SVD. , MPG was 10.7 and 10.6 mm Hg; AVA was
1.6 and 1.5 cm2 in the TAVR and SAVR groups
Echocardiography evaluation of the CoreValve
system performance over 5 years of follow-up.
Lack of any significant
increase in transvalvular mean
gradient over 5 years FU

61. Subclinical changes on echocardiography should probably alert
clinicians about possible structural changes within the
bioprosthesis warranting several considerations :
1) Additional imaging tests to confirm/dismiss a more relevant SVD;
2) Closer follow-up considering that the time period between subclinical
and clinically relevant SVD remains unknown; and
3) A more aggressive therapeutic approach to address modifiable risk
factors that promote atherosclerotic disease, which in turn may play a
role in the progression of SVD

62. INOPERABILITY: DOES IT EXIST?
WHAT ARETHE MAIN PATIENT &TECHNICAL
CONSIDERATIONS?

63. Characteristics of an Inoperable Patient
Cohort B
Old age
Reduced EF
Prior CABG
History of stroke/CVA
History of AFib
Prior chest radiation
Prior open chest surgery
Heavily calcified aorta
History of CAD
History of COPD
History of renal insufficiency
Frailty
History of syncope
Fatigue, slow gait
Peripheral vascular disease Diabetes and hypertension
Severe, symptomatic native aortic valve stenosis
TAVR patients may present with some of the following:

64. Medical Comobidities and factors
predicting poorer outcomes postTAVI

65. How do you decide if someone
shouldn’t have surgery?

66. How do you decide if someone
shouldn’t have surgery?
It’s not just about the STS risk score

67. Specific Patient Populations
Frailty
Frailty
Impairment in multiple
systems that leads to a
decline in homeostatic
reserve and resiliency
Charlson
Co-Morbidities
Two or more medical
conditions
Disability
ADL
IADLs
Difficulty or
dependency in daily
living
5.7%
21.5%
46.2%

68. Specific Patient Populations
Concomitant Coronary Artery Disease (CAD)
 50–75% of patients undergoingTAVI have co‐existent CAD.
Patients undergoing AVR with severe CAD are routinely
offered concomitant coronary artery bypass grafting in view of
established mortality benefit.
 Studies suggested that patients with pre‐existing CAD have a
higher risk of ischaemic events, major adverse CV events &
mortality.
 However, registry data & meta-analysis suggested that
co‐existent CAD is not an independent prognosticator for
all‐cause mortality
 The timing of revascularisation remains equally unclear.
Performing percutaneous coronary intervention (PCI) before
TAVI in patients with significant CAD appears to be feasible
and without associated increase in post‐procedural morbidity.

69. Specific Patient Populations
Renal Impairment
 Dialysis‐dependant patients to have higher burden of
congestive heart failure, in‐hospital mortality and short‐term
mortality post‐TAVI compared to those not requiring dialysis.
 Analysis of the UKTAVI registry has indicated that CKD confers
adverse risk in a graded fashion, with those of severe
impairment at highest risk.
 TAVI itself is associated with higher rates of post‐procedural
AKI than AVR, with an estimated incidence around 12%.

70. Specific Patient Populations
Bicuspid AorticValve
• Bicuspid aortic valves become more frequent in younger patients with severe AS
• When TAVR is applied to “all-comers,” this anatomy becomes an important issue
• Significantly more work needs to be done to learn optimal implant techniques
and device designs for this anatomical variation
69%
60%
39%
26%
0%
20%
40%
60%
80%
100%
50s 60s 70s 80s
%withBicuspidAorticValve
Patient Age
Severe Aortic Stenosis Patients with BicuspidValve
1Roberts, et al., Circulation 2005;111:920-25

71. Specific Patient Populations
Why Bicuspids Are Problematic forTAVR?
 Bulky Eccentric Calcification
 Incomplete valve expansion
 Paravalvar leak
 Annulus rupture
 Higher PPM Rate
 Abnormal/lower coronary orifices
 Ascending Aortopathy- 25%
 NeedsTreatment
 Risk of rupture/dissection
 Ovality of annulus
 Risk of paravalvar leak
 Long-term durability of theTAVI valve?
 For these reasons bicuspid valves had been excluded from all
randomized trials

72. Specific Patient Populations
Bicuspid AorticValve
 Previously considered a relative contraindication forTAVI,
based on concerns that associated annular dilatation would
result in poor seating & subsequent malfunction of the
bioprosthesis.
 Prospective studies comparing BAV and non‐BAV have shown
comparable success rates and pressure gradients
post‐deployment.
 Higher incidence of post‐procedure transvalvular AR, although
use of newer‐generation devices with an outer fabric skirt does
appear to offer some improvement.
 Recent data suggest higher incidence of conduction
disturbance requiring permanent pacemaker (PPM), with
implantation depth and over‐sizing of devices potentially
attributable.

73. Informed Shared Decisions for Patients with AS
Catherine M Otto
 We tend to “over-extrapolate”
current trends into the future
 We tend to pay more attention
to alarmists than to thoughtful,
knowledgeable opinions
 Companies, interest groups and
activists often have a personal
interest in exaggerating
=> Stay calm. Do not “follow the
crowd”. Look at facts!

74. When ShouldWe OfferValve Intervention?

75. Informed Shared Decisions for Patients with AS
 It is important to remember thatAT PRESENT therapeutic
decisions, particularly those related to corrective surgery, are
based largely on the presence or absence of symptoms.
 “Estimated surgical risk no longer dictates the choice between
surgery andTAVR; instead the primary considerations are life
expectancy and valve durability, both of which are related to the
patient’s age”
 The durability of surgical AVR is inversely related to the patient’s
age at time of valve replacement; the 15 yr risk of reoperation is
~5% among those who are 70 yrs compared with 25% among
patients who are 50 yr old
 So, how is your patient different from
clinical trials?

76. SuccessfulTAVR Is NotThe Endpoint!
AsTAVR is applied to younger patients, new strategies will be needed
to manage inevitable clinical realities later in their lives
Strategies to manage CAD post TAVR
will be needed
Redo TAVR or surgical revision will be
required for a subset of patients

77. KEYTAKEAWAYS
 Aortic Stenosis is prevalent with a high morbidity and mortality
when symptomatic and aortic valve replacement is the only
treatment associated with improved outcomes.
 TAVR is now proven in patients across the entire spectrum of
surgical risk, as an alternative therapy to AorticValve Surgery, but
increased risk of stroke and vascular injury and the need for a
permanent pacemaker.
 Consideration of surgery in an asymptomatic patient with severe AS
requires an appreciation of the relative risks of surgical and medical
therapy. More trials needed in younger patients at low surgical risk,
moderate aortic stenosis and heart failure, and for asymptomatic
patients with severe AS.
 While certainTAVR-specific complications remain a concern, the
survival advantage and quick recovery to improved quality of life
provide a highly encouraging signal.

78. Patient-focused Multi-disciplinary HeartTeam Approach
Confirm the patient is
diagnosed with severe
symptomatic native
aortic stenosis
Confirm the patient
has been
independently
evaluated by two
cardiac surgeons and
meets the indication
forTAVR
Evaluate the
aortic valvular
complex using
echocardiography
Evaluate the
peripheral
vasculature and aortic
valvular complex
using MDCT
Evaluate the peripheral
vasculature and aortic
valvular complex using
catheterization
4 531 2

79. KEYTAKEAWAYS