Surgical or Transcatheter Valve Surgery: What Your Patients Need To...

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

Scope
• Pathophysiology of aortic stenosis & risks
• Types of intervention & potential complications
• Current guideline, ...

• In his 1958 Nathanson lecture, Dr PaulWood argued
prophetically that “aortic stenosis is a simple
mechanical fault which...

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

Number of deaths per year due to heart valve disease

Aortic Sclerosis  Aortic Stenosis
 Aortic sclerosis: ~25% of
population over 65-74 yrs;
48% of people over age of
84 yrs...

Progression of Aortic Sclerosis to Stenosis
400 patients, leaflet sclerosis and initial velocity Vmax <2 m/s
Vmax >3.0: mi...

Prevalence of Aortic Stenosis
16.5 Million People in US
Over the Age of 652
7%
Percentage
Diagnosed with
Aortic Stenosis
...

What Causes Aortic Stenosis in Adults?
Aortic stenosis in patients
over the age of 65 is
usually caused by calcific
(calci...

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

*
Echocardiographic Guidelines are the Gold Standard
in Assessing Severe Aortic Stenosis
• According to the 2014 ACC/AHA g...

Disease Stages in Aortic Stenosis

AS is life-threatening & rapidly progressive
- Survival after onset of symptoms is
50% at 2 years and 20% at 5 years1
- Su...

Mortality of Nonsurgically treated patients
with severe aortic stenosis

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, ...

Source: Robert O. Bonow et al. ACC/AHA 2006 guidelines for the management of patients with valvular heart disease: a repor...

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

• Studies show at least 40% of patients with severe AS are not treated with an AVR9-15
Low Percentage of AorticValve Surge...

Surgery versus MedicalTherapy
 OPERATIVE RISK OF AVR
 SUDDEN DEATH RISK NOTTOTALLY ABOLISHED
 PROSTHETICVALVE COMPLICAT...

• Successful BAV in 80.8%, In-hospital major comp 6.8%, Death 2.5%
• 56% mortality after single BAV at 1 year
• Patients b...

Most would agree
 It may be used for patients who have symptomatic AS in need of
emergent noncardiac surgery.The hemodyna...

Evolution ofAS surgery
• The recommendations for choice of intervention for AS take into consideration the
surgical risk, ...

SUPPORTING EVIDENCE

Patients at Extreme Surgical Risk
Foundational trials tested new TAVR therapy in patients without
the option for a surgica...

• Cohort B of PARTNERS randomized to TAVR had lower rates of all-cause mortality
(30.7% vs. 50.7%, P < .001), cardiovascul...

Edwards SAPIENTHV Improved Cardiac Function and
Heart Failure Symptoms
THE PARTNERTRIAL COHORT B
Dramatic reduction in mea...

Complications
THE PARTNERTRIAL COHORT B
The 3-year mortality rate in the TAVR and standard therapy groups was 54.1%
and 80...

Patients at High Surgical Risk
Trials randomizing high risk patients to either TAVR or SAVR
soon followed
US CoreValve Piv...

• 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...

• The CoreValve Pivotal Trial was the first to show a survival advantage with TAVR
compared to SAVR, with separation of th...

Patients at Intermediate Surgical Risk
Randomized trial data comparing TAVR to SAVR in lower-
risk patients recently becam...

• The PARTNER 2A Trial showed that TAVR with SAPIEN XT was non-inferior to surgery
for the primary endpoint of all-cause m...

Primary outcome of all-cause mortality and disabling stroke was similar at an
estimated 12.6 percent and 14.0 percent in t...

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

Patients at Low Surgical Risk
Medtronic Low Risk PARTNER 3
Primary Endpoint Death or major stroke at 2 years
Death, all st...

Patients at Low Surgical Risk
Key Exclusion Criteria
Medtronic Low Risk PARTNER 3
• Bicuspid aortic valve • Bicuspid aorti...

Though the study was likely under-powered, NOTION showed all-cause mortality with TAVR
with CoreValve to be non-inferior t...

Patients at Low Surgical Risk
PARTNER 3 | Balloon-expandable SAPIEN 3
N Engl J Med 2019; 380:1695-1705
Rate of the primary...

Patients at Low Surgical Risk
Medtronic TAVR RCT in Low Risk Patients
N Engl J Med 2019; 380:1706-1715
• For the primary e...

WE REMAIN COGNIZANTTHAT CERTAIN
TECHNICAL CHALLENGES NEEDTO BE
ADDRESSED

SpecificTechnicalConsiderations
Strokes
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll Cardiol I...

SpecificTechnicalConsiderations
New Permanent Pacemaker Implantation
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb...

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

SpecificTechnicalConsiderations
Vascular Complications
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am...

SpecificTechnicalConsiderations
Patient Prosthesis Mismatch

Incidence & Impact on Mortality of PPM following AVR

SpecificTechnicalConsiderations
Patient Prosthesis MismatchPercentageofpatients
Patient Prosthesis Mismatch was defined as...

SpecificTechnicalConsiderations
Patient Prosthesis Mismatch
Zorn et al J Thorac Cardiovasc Surg 2015; epub before print
Se...

SpecificTechnicalConsiderations
Paravalvular Leak
1Leon, et al., N Engl J Med 2010;363:1597-1607; 2Webb, et al., J Am Coll...

StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis
SVD is not usual (≤15%) during the first decade post-...

StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis

Structural Valve
Deterioration (SVD)
A valve-centered
endpoint
Bioprosthetic Valve
Failure (BVF)
A patient-centered
endpoi...

BioprostheticValve Dysfunction
EAPCI/ESC/EACTS Standardized Definitions

MECHANISMS OF VALVEFAILURE
AdaptedfromSalaunE,etal.Heart.2018;104:1323-1332
Patient RelatedFactors
Dyslipidemia |Diabetes ...

AdaptedfromSalaunE,etal.Heart.2018;104:1323-1332 CapodannoD,etal.EurHeartJ. 2017;38:3382-3390
Structural ValveDeterioratio...

StructuralValve Deterioration is the Achille’s Heel of
Bioprosthesis
Rodriguez-Gabella T et al. J Am Coll Cardiol 2018;71(...

Years of Follow-Up on Commercially AvailableValves &
Meta-Analysis ofTranscatheterValve Failure
Accelerated wear testing
h...

Limited data onTAVR durability, but
TAVR had significantly better valve performance over SAVR
PARTNER 5-Year Echo Prosthet...

Subclinical changes on echocardiography should probably alert
clinicians about possible structural changes within the
biop...

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

Characteristics of an Inoperable Patient
Cohort B
Old age
Reduced EF
Prior CABG
History of stroke/CVA
History of AFib
Prio...

Medical Comobidities and factors
predicting poorer outcomes postTAVI

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

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

Specific Patient Populations
Frailty
Frailty
Impairment in multiple
systems that leads to a
decline in homeostatic
reserve...

Specific Patient Populations
Concomitant Coronary Artery Disease (CAD)
 50–75% of patients undergoingTAVI have co‐existen...

Specific Patient Populations
Renal Impairment
 Dialysis‐dependant patients to have higher burden of
congestive heart fail...

Specific Patient Populations
Bicuspid AorticValve
• Bicuspid aortic valves become more frequent in younger patients with s...

Specific Patient Populations
Why Bicuspids Are Problematic forTAVR?
 Bulky Eccentric Calcification
 Incomplete valve exp...

Specific Patient Populations
Bicuspid AorticValve
 Previously considered a relative contraindication forTAVI,
based on co...

Informed Shared Decisions for Patients with AS
Catherine M Otto
 We tend to “over-extrapolate”
current trends into the fu...

When ShouldWe OfferValve Intervention?

Informed Shared Decisions for Patients with AS
 It is important to remember thatAT PRESENT therapeutic
decisions, particu...

SuccessfulTAVR Is NotThe Endpoint!
AsTAVR is applied to younger patients, new strategies will be needed
to manage inevitab...

KEYTAKEAWAYS
 Aortic Stenosis is prevalent with a high morbidity and mortality
when symptomatic and aortic valve replacem...

Patient-focused Multi-disciplinary HeartTeam Approach
Confirm the patient is
diagnosed with severe
symptomatic native
aort...

KEYTAKEAWAYS

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