Surgical options for aortic stenosis

Surgical options for aortic stenosis

F MAISANOF MAISANO

Evolving scenario of valve diseseEvolving scenario of valve disese

Aging / Increased life expectancy

Changing style of life Quality of life over longevity Productivity Esthetic appearance

Circulation of information Patients awareness Referral pattern

Limited resources / cost containment

AVR: state of the artAVR: state of the art

about 300.000 operations/yr

More than 40 years of clinical experience

Prostheses are reliable

Predictable and low risks

Long term results available

STS DATABASESTS DATABASEAVR

n 32,968

Mortality 4.0%

Stroke 1.5%

Prolonged Ventilation 7.07%

Reoperation 4.12%

Renal Failure 3.7%

MedPAR DataMedPAR Data

Long term OutcomesLong term Outcomes

Eichinger et al Annals thorac Surg 2008

Durability Survival

TAVI: a new tool for the high risk patients TAVI: a new tool for the high risk patients

Aortic valve surgery in the era of TAVIAortic valve surgery in the era of TAVI

TAVI as a complementary procedure for patients with contraindications Clinical Technical

TAVI as an alternative procedure High risk Moderate risk Low risk

AVR in the context of TAVI Prosthesis choice timing

Technical contraindicationsTechnical contraindications

Previous chest radiationPorcelain aortaMultiple previous sternotomies (esp. with open grafts)

Clinical contraindicationsClinical contraindicationsAge

Euroscore, STS score

Severe comorbidities Liver failure Renal failure (dialisis) COPD Neoplasia

frialty

30% of elderly patients are denied surgery30% of elderly patients are denied surgery

Age and mortalityAge and mortality

Euroscore logistic risk for valve surgery

assuming no comorbidities

Euroscore logistic risk for valve surgery

assuming no comorbidities

Aging epidemicsAging epidemics

According to the EC, the number of european citizens aged 75yrs or more is going to be 64M in 2025

x 4 x 7

IIASA, committee of the ECC, 2007

Prevalence of valve disease: AS is epidemic in the elderlyPrevalence of valve disease: AS is epidemic in the elderly

Nkomo et al , Lancet 2006

Risk benefit analysis in the elderlyRisk benefit analysis in the elderly

Evaluation of operative riskEvaluation of operative risk

Risk Operative mortality Morbidity

• Short term • Long term

Benefit• Survival• Quality of life

Common comorbidities in older patientsCommon comorbidities in older patients

Condition implications

Renal dysfunction Exacerbated by diuretics and ACE inhibitors

Chronic lung disease Contributes to uncertainty about diagnosis /volume status

Cognitive dysfunction Interferes with dietary, medication, activity compliance

Depression , social isolation

Worsen prognosis, interferes with compliance

Postural hypotension, falls Exacerbated by vasodilators, diuretics, blockers

Urinary incontinence Aggravated by diuretics, ACE inhibitors (cough)

Sensory deprivation Interferes with compliance

Nutritional disorders Exacerbated by dietary restrictions

Polypharmacy Compliance issues, drug interactions

Frailty Exacerbated by hospitalization; increased fall risk

How do you define debility or fraility ?How do you define debility or fraility ?

•Same age and predicted risk•One passes the “eyeball test”; one doesn’t•Fraility Index

Frailty of the elderlyFrailty of the elderly

Reduction of organ reserve Reduced resistance to

injury Reduced adaptability

Reduced physical activityReduced neurocognitive functionDepression

High to moderate riskHigh to moderate riskRisk of surgery

Risk of TAVI

Aortic Valve SurgeryPredictive Risk AlgorithmsAortic Valve SurgeryPredictive Risk Algorithms

STS

EuroSCORE (additive)

EuroSCORE (logistic)

Ambler (UK)

Northern New England

New York State

Providence Health System

Problems with Risk AlgorithmsProblems with Risk AlgorithmsAll risk algorithms are based on operated patients and don’t factor in “inoperable “ patients

Outcomes other than mortality are not predicted, e.g., stroke, discharge disposition, QoL

Many risk variables not included

Variables Not Included In Risk Algorithms In Patients Undergoing AVR Variables Not Included In Risk Algorithms In Patients Undergoing AVR

Previous chest radiation Oxygen dependence Reoperative patients with open grafts Previous tissue valve replacement Porcelain aorta Advanced liver disease/cirrhosis Degenerative neurocognitive disorders- Alzheimer’s Frailness or debility

Euroscore overestimates the actual risk in the high risk populationEuroscore overestimates the actual risk in the high risk population

Osswald B, et al. European Heart Journal (2009) 30, 74–80

Leontyev et al Ann Thorac Surg 2009

Risk of TAVIRisk of TAVIAscending aorta aneurysm

Uneven or massive valve calcification

Bicuspid valve

Previous mitral valve prosthesis

Access issues

Severe renal failure

Bicuspid vs tricuspid valveBicuspid vs tricuspid valve

Bicuspid Aortic ValveBicuspid Aortic Valve

Valve area and calcium detectionValve area and calcium detection

TAVI screeningTAVI screening

3232 di 22 di 22

Valve Team Hsr

Nov 2007-May 2009

82 TAVI

69 Transfemoral approach

10 Transapical approach

3 Trans-subclavian approach

Patient baseline clinical characteristics (n=82)

Procedural outcomes (n=82)

Survival

Actuarial survival at 12 months: 88.1±4.3%

April 9, 2023Data Snapshot37

The SOURCE Registry Cohort One

TF (n=459) TA (n=571)

30 day 93.7% 89.7%

EuroSCORE <20 94.6%(Mean 12.5)

93.4%(Mean 12.4)

EuroSCORE >20 93.3%(Mean 33.7)

63% of pts

88.1%(Mean 36.3)

70% of pts

Survival

0.6

0.65

0.7

0.75

0.8

0.85

0.9

0.95

1

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

Su

rviv

al

< 20 >= 20

SOURCE 30 Day All Cause Mortality -- Transfemoral ApproachStratified by Logistic EuroSCORE

SOURCE 30 Day All Cause Mortality -- Transapical ApproachStratified by Logistic EuroSCORE

0.6

0.65

0.7

0.75

0.8

0.85

0.9

0.95

1

0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1

Fraction of Months post Procedure

Su

rviv

al

< 20 >= 20

p=0.068

Survival of TA pts with ES< and >20 are significantly different (93.4 vs. 88.1) (p=0.067)

Patients entering the VALVETEAM screening process (n=181)Patients entering the VALVETEAM screening process (n=181)

TAVI vs Surgical AVR

Challenging clinical scenariosChallenging clinical scenariosBicuspid valves

CAD + AS

Non severe AS in pts undergoing CABG

Renal failure patients

Dye allergy

Health economics

Current surgical candidatesCurrent surgical candidatesMinimization of invasiveness To mitigate risks Increase acceptance

Tailored treatment Anatomical substrate Underlying disease Patient needs

•Perioperative care•Pain management•Best prosthetic material

•Perioperative care•Pain management•Best prosthetic material

Surgical Approaches: Conventional and Minimally

Invasive Cardiac Surgery

Surgical Approaches: Conventional and Minimally

Invasive Cardiac Surgery

Conventional Minimally Invasive

Minimally invasive surgeryMinimally invasive surgeryMini-incisions

Abolition of CPB

Conventional and Minimally Invasive IncisionsConventional and Minimally Invasive Incisions

Mitral Valve SurgeryAortic Valve Surgery

Soft Tissue Retractor Placement –Used For Exposures in Minimally Invasive Cardiac SurgerySoft Tissue Retractor Placement –Used For Exposures in Minimally Invasive Cardiac Surgery

Level 3: RoboticsLevel 3: RoboticsFemoral Arterial & Venous Cannulation

Optional Direct Cannulation With Straight Shot Cannula

IJ Coronary Sinus Catheter

IJ Pulmonary Vent

EndoClamp Occlusion Balloon

Only Mitral Valve Replacements, Mitral Valve Repairs, ASDs & CABG Can Be Done At This Time

Trans-incision Visualization –The Aortic ValveTrans-incision Visualization –The Aortic Valve

AVR – CHOICE OF THE PROTHESISAVR – CHOICE OF THE PROTHESIS

Barnett et al JTCVS 2009

The revalving conceptThe revalving concept

Expanding durabiltyExpanding durabilty

Is valve device industry investing in surgical AVR?Is valve device industry investing in surgical AVR?

Minimally invasive approaches

Sutureless valve

No anticoagulation

More durable tissue valves

Exchangeable valves

Valve-X-change: the lifetime valveValve-X-change: the lifetime valve

Zlotnick et al Circulation 2008

Apicoaortic conduitsApicoaortic conduits

Edwards SAPIENEdwards SAPIEN™™ THV THV Edwards SAPIENEdwards SAPIEN™™ THV THV

Subclavian access (Corevalve TM)Subclavian access (Corevalve TM)Subclavian access (Corevalve TM)Subclavian access (Corevalve TM)

Short delivery distanceShort delivery distance

PainlessPainless

Local anesthesiaLocal anesthesia

Retrograde approachRetrograde approach

conclusionsconclusionsAortic stenosis can be treated with low risk in different ways

Percutaneous and transcatheter modalities are emerging

Guidelines will be revised

Open mind and collaborative efforts are key

Clinical wisdom is today the only tool available to guide the decision