Valve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal

Valve Disease in Patients With Heart Failure TAVI or Surgery? Miguel Sousa Uva Hospital Cruz Vermelha Lisbon, Portugal

I have nothing to disclose.

Wide Spectrum Stable vs Decompensated NYHA II IV? Ejection Fraction: Reduced vs Preserved Symptoms Correlate Poorly With Ventricular Function

Aortic Stenosis in Patients With Heart Failure And Reduced Ventricular Function TAVI or Surgery?

TAVI vs Surgery Heart Failure + LV Dysfunction What Are The Goals? 1. Lowest Mortality 2. Lowest Morbidity 3. Recovery of LV Function 4. Good Valve Hemodynamics 5. Persistent Long Term Outcomes

Predictors of Mortality After Surgery Aortic Stenosis With Heart Failure and Reduced Ventricular Function

Results of Surgery in Severe Aortic Stenosis Ejection Fraction < 35% Mortality 30 d: 4-12% Survival 5 Years: 65-70% Predictors of Mortality: LVESVI, CardioThoracic Index Coronary Artery Disease Mean Gradient Ejection Fraction (Late Mortality) Connoly,, Circulation 1997 Vaquette, Heart 2005 Chukwuemeka, EJTCS, 2006 Pai Ann ThoracSurg, 2008 Ding, Eur Heart J 2009 Halkos, Ann Thorac Surg 2009 Chikwe, Am J Cariol, 2009

Functional Results of Surgery Aortic Stenosis With Ejection Fraction < 35% 120 100 80 60 40 NYHA II NYHA III IV 20 0 Pre Op Post Op Connoly Circulation 1997 Vaquette Heart 2005 Pai Ann ThoracSurg 2008 Ding Eur Hear J 2009

NYHA III-IV + EF 30% N = 155 30 Day Mortality : 12% Independent Predictor : CardioThoracic Ratio 0.6

Change in Ejection Fraction 80% Have Improved EF c N = 55 (44%) > 10 EF Units c < 10 EF Units

Survival Depends on Recovery of Ejection Fraction Predictors of EF >10% 1/ CardioThoracicRatio 2/ Mean Gradient

PPM: AVA <0.85cm2/m2 J Thorac Cardiovasc Surg 2006;131:1036-1044

TAVI & Heart Failure / LV Dysfunction What Do We Know?

N = 147 EF<50% vs EF 50%

No Mortality Difference (But Higher MACCE)

No Survival Difference With Matched SAVR

Circ Cardiovasc Interv.2012; 5: 253-260 LVEF N 30d Mortality 1 Year Survival 35% 50 10% 69% >35% 334 3% 87% Predictors of Late Mortality: 1. Congestive Heart failure 2. Log EuroSCORE 3. Moderate-Severe PeriValvular Leak P=0.01 p<0.001

3195 patients FRANCE 2 Registry Log EuroSCORE 21.9±14.3% STS score 14.4±12.0% At 1 year Stroke 4.1% Periprosthetic Aortic Regurgitation 64.5%. Independent predictors of 1-year mortality o Increased logistic EuroSCORE, o NYHA functional class III or IV otransapical approach operiprosthetic regurgitation grade 2 or more N Engl J Med 2012;366:1705-15.

FRANCE 2 Registry N Engl J Med 2012;366:1705-15.

What Is The Impact of Coronary Artery Disease?

Associated CABG http://www.sts.org/sites/default/files/documents/ pdf/ndb2010/1stharvestexecutivesummary%5b1%5d.pdf.

What About TAVI + Coronary Disease? RCTs Excluded Patients Requiring Revascularization Extent of CAD Impacts Safety AND Long Term Durability EF=30% + NYHA IV + 3 Vessel Disease: Is TAVI Safe?

PCI in Severe Aortic Stenosis

Low Flow Low Gradient and Reduced Ejection Fraction

Prognostic Impact of Low Gradient and/or Reduced EF After TAVI Reduced EF, Low Gradient Preserved EF, High Gradient

Decompensated Heart Failure & Aortic Stenosis

Role of Balloon Valvuloplasty Recovery High Risk TAVI

Decompensated Heart Failure J Thorac Cardiovasc Surg 2012;143:1356-1363 EF 10%-25% N = 21 Log EuroScore 66% 30 D Mortality: 4.8% No Neuro Events Post Op EF 38% 1 y Survival 76%

TAVI vs SAVR in Severe AS and Reduced LV Function

TAVI EF 50% SAVR N 83 200 On multivariable analysis, the predictors of absolute change in LVEF after the procedure were female gender (P 0.004), absence of atrial fibrillation (P 0.01), baseline LVEF (P 0.005), TAVI (P 0.007), AVA (P 0.01), and complete or no need for coronary revascularization (P 0.01) Mortality 30d 19% 13% EF >50% 1 Y 58% 20% A Regurgitation 37% 5%

Change in Ejection Fraction Predictors of absolute change in LVEF: Whole Cohort -Female gender -Absence of atrial fibrillation -Baseline LVEF -TAVI -Greater Increase AVA -Complete or no need for coronary EF < 35% revascularization Circulation. 2010;122:1943-1951.

How Do We Decide? TAVI or Surgery?

TAVI vs Surgery in Heart Failure Gaps in Knowledge Limitations of The Evidence No Randomized Studies Different Cut Offs for Ejection Fraction Aortic Stenosis as Continuum: High Gradient Low Ejection Fraction Low Gradient Low Ejection Fraction: Few Patients Selection Bias Publication Bias: Learning Curve Results UnderReported

N Engl J Med 2012;366:168695.

Circulation. 2012;126:720-728. LBBB=34% Multivariate Cox Regression All-Cause Mortality Female Sex Creatinine COPD LVEF<50% TAVI Induced LBBB

Consequences of Pace Maker Induced Dyssynchrony? European Journal of Heart Failure (2010) 12, 889 892

Risk Assessment Conditions Requiring Individual Approach Low Flow Low Gradient AS Conditions Likely To Be Associated With Insufficient Validation Requiring Further Study LV Dilatation, Diastolic Dysfunction, RV Dysfunction

The Heart Team Risk Assessment No Decision Without MultiDisciplinary Clinical Judgement SURGEON CARDIOLOGISTS Imaging specialists (Echo, CT, MRI) Surgery Or TAVI? Anesthesiologist Gerontologist

What Do Guidelines Say?

If mean gradient is >40 mmhg, there is theoretically no lower EF limit for aortic valve replacement in symptomatic patients with severe aortic stenosis.

In patients not medically fit for surgery transcatheter aortic valve replacement should be considered

Take Home Messages (1) 1. Advanced Heart Failure and/or Reduced Ejection Fraction Increases the Risk of Early and Late Death After AVR But Also After TAVI 2. Risk Is Higher in Patients With Low Flow Low Gradient AS, No Contractile Reserve, Coronary Disease, Large Ventricles and NYHA III/IV 3. TAVI Provides Better Hemodynamic Than SAVR But More Aortic Regurgitation and Pace Makers 4. Surgical AVR is A Safe, Effective and Durable Option Which Should Not Be Denied to Patients On The Basis of Low LVEF Alone

Take Home Messages (2) 5. Avoid Patient Prosthesis Mismatch Since Depressed LV Systolic Function Patients Are Most Vulnerable to Residual LV Afterload Associated With PPM 6. TAVI May Provide a Good Alternative to Surgical AVR in patients with severe AS and Depressed Left Ventricular Systolic Function At High or Prohibitive Surgical Risk, Due to Severe Comorbidities, Small Aortic Root, and/or Lack of Myocardial Contractile Reserve. 7. Heart Team Based Approach Foundational Requirement for Risk Assessment, Decision Making, and Patient Information

Thank You for Your Attention

J Am Coll Cardiol 2012;59:280 7. As TAVI becomes more routine and widely available, operators may be tempted to implant the device in younger patients with less comorbidities. Uncertainties about the long-term durability, in addition to the unresolved issues of paravalvular aortic regurgitation and conduction abnormalities, should be cautiously weighed against the immediate benefits being widely reported.

Survival % Natural history of symptomatic Aortic Stenosis is very bad without treatment TAVI vs AVR 100 80 60 40 20 0 Onset of severe symptoms Latent period (increasing obstruction, myocardial overload) 0 40 50 60 70 80 Age yr Angina Syncope Failure 0 2 4 6 Average survival (yr) Average age death (male) Ross J, Braunwald E. Aortic stenosis. Circulation.1968; 38 [Suppl 5]:61-7

LV End Systolic Volume Index

N = 254 EF 30% 5.4% EF > 30% 1.2% 30 D Mortality p <0.01 STS 10% 10.4% STS < 10 0% <0.01 <

Surgical Aortic Valve Replacement Does Ejection Fraction Influence Mortality? Rahimtoola Eur Heart J 2008;;29:1783

Current Risk Scores Do Not Provide Reliable Estimate of Operative Mortality Specific Risk Models Should Be Developed for TAVI Future Risk Scores Should Include: Cognitive Status Functional Capacity, Nutritional Status

Cathet Cardiovasc Interv 2012;79:693-701

TAVI in Low-Flow, Low Gradient Aortic Stenosis Low Flow Low Gradient (N=15) 33% No LF/LG (N=152) 13% Mortality (6 Months) P < 0.037 Ejection Fraction Survivors N=10 Cathet Cardiovasc Interv 2012;79:693-701

Low Flow Low Gradient Aortic Stenosis 5 Year Survival All patients N = 81 SAVR Medical p 54% 13% <0.001 Propensity Matched 65% 11% <0.02 despite a high operative mortality of 22%

No Contractile Reserve Influence of Mean Gradient and Coronary Disease JACC 2009;53:1865-73

Predictors of mortality after aortic valve replacement. Tjang Y S et al. Eur J Cardiothorac Surg 2007;32:469-474