LowFlow LowGradient Aortic Stenosis with Normal and Preserved

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Low-Flow, Low-Gradient Aortic Stenosis with Normal and Preserved LVEF Philippe Pibarot, DVM, Ph. D,

Low-Flow, Low-Gradient Aortic Stenosis with Normal and Preserved LVEF Philippe Pibarot, DVM, Ph. D, FACC, FAHA, FESC Canada Research Chair in Valvular Heart Diseases Institut Universitaire de Cardiologie et de Pneumologie de Québec / Québec Heart & Lung Institute Université LAVAL

Disclosure Statement of Financial Interest I, Philippe Pibarot , DO NOT have a financial

Disclosure Statement of Financial Interest I, Philippe Pibarot , DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

Two Different Patterns of Low-Flow, Low-Gradient AS NORMAL-LVEF NORMAL-FLOW HIGH-GRADIENT 50 -70% Pibarot &

Two Different Patterns of Low-Flow, Low-Gradient AS NORMAL-LVEF NORMAL-FLOW HIGH-GRADIENT 50 -70% Pibarot & Dumesnil JACC, in press NORMAL-LVEF «PARADOXICAL» LOW-FLOW LOW-GRADIENT 10 -25% LOW-LVEF «CLASSICAL» LOW-FLOW LOW-GRADIENT 5 -10%

Low-Flow, Low-Gradient Severe? AS True-Severe AS Normal Flow Low Flow AVA ∆P Gradient =

Low-Flow, Low-Gradient Severe? AS True-Severe AS Normal Flow Low Flow AVA ∆P Gradient = Q 2 K AVA 2 Pseudo-Severe AS Low Flow Normal Flow

LVEF≤ 40% ΔP<40 AVA≤ 1. 0 Dobutamine-Stress Echo SV < 20 % SV ≥

LVEF≤ 40% ΔP<40 AVA≤ 1. 0 Dobutamine-Stress Echo SV < 20 % SV ≥ 20 % Contractile (Flow) Reserve ΔP≥ 40 AVA<1. 0 -1. 2 No Contractile (Flow) Reserve ΔP<40 & AVA ≥ 1. 0 -1. 2 AS Severity: Indeterminate MSCT: Ca Score ≥ 1650? No Yes True-Severe AS Pseudo-Severe AS True-Severe AS SAVR CABG MEDICAL Rx TRIAL SAVR (High Op. Risk) TAVR?

Outcome of Pseudo-Severe AS Under Conservative Treatment Pseudo Severe AS: ΔP<40 & AVA ≥

Outcome of Pseudo-Severe AS Under Conservative Treatment Pseudo Severe AS: ΔP<40 & AVA ≥ 1. 2 at DSE 29 % had PSAS Fougères et al. Eur Heart J. 2012

Performance of MSCT Calcium score > 1651 AU Case study #3 to correctly differentiate

Performance of MSCT Calcium score > 1651 AU Case study #3 to correctly differentiate severe from non-severe AS Score: 2010 Cueff et al. Heart 97: 721 -6, 2011

Total Population Matched Patients Tribouilloy et al. JACC, 53; 1865 -1873, 2009

Total Population Matched Patients Tribouilloy et al. JACC, 53; 1865 -1873, 2009

2012 ESC/EACTS Guidelines on Management of VHD: Indications for AVR in AS Vahanian et

2012 ESC/EACTS Guidelines on Management of VHD: Indications for AVR in AS Vahanian et al. EHJ 2012

“Paradoxical” Low-Flow, Low-Gradient AS with Preserved LVEF ↑Age Women Hypertension Met. S – Diabetes

“Paradoxical” Low-Flow, Low-Gradient AS with Preserved LVEF ↑Age Women Hypertension Met. S – Diabetes Hachicha Z et al. , Circulation, 2007 Dumesnil et al. Eur Heart J, 2009 Pibarot & Dumesnil JACC, in press, 2012

Ø 75 y. o. female Case Study Ø Calcific AS Ø NYHA class III

Ø 75 y. o. female Case Study Ø Calcific AS Ø NYHA class III Ø No CAD at angio Ø LVEF: 70% Ø LVEDV: 38 m. L/m 2 Ø SVi: 26 m. L/m 2 Ø AS severity at catheter: Ø AVA: 0. 8 cm 2 Ø Indexed AVA: 0. 5 cm 2/m 2 Ø Mean gradient: 32 mm. Hg Courtesy of Dr G Dreyfus, Monaco Hospital

Doppler-Echo Features of Paradoxical Low-Flow, Low-Gradient AS The Aortic Valve: Ø Ø AVA< 1.

Doppler-Echo Features of Paradoxical Low-Flow, Low-Gradient AS The Aortic Valve: Ø Ø AVA< 1. 0 cm 2 AVAi < 0. 6 cm 2/m 2 DVI<0. 25 Severely thickened/calcified valve Mean gradient <40 mm. Hg Valvulo-arterial impedance > 4. 5 The Left Ventricle Ø Ø Ø Ø EDD<47 mm EDV< 55 m. L/m 2 RWT ratio > 0. 50 Myocardial fibrosis Impaired LV filling LVEF > 50% GLS < 15% SVi < 35 m. L/m 2 Pibarot & Dumesnil, JACC 58; 413 -415, 2011

Prevalence of Paradoxical Low-Flow, Low-Gradient AS Prevalence (%) Hachicha 2006 Echo (512 pts) Barasch

Prevalence of Paradoxical Low-Flow, Low-Gradient AS Prevalence (%) Hachicha 2006 Echo (512 pts) Barasch 2006 Echo (215 pts) Cramariuc 2009 Echo (1591 pts) Minners 2010 Echo (333 pts) Minners 2010 Cath (333 pts) Hermann 2011 Echo & Cath (86 pts) Adda 2011 Echo (150 pts) Lancellotti 2012 Echo (150 pts) Paradoxical Low-Flow, Low-Gradient AVA<1. 0 cm 2; MG<40 mm. Hg LVEF>50%; SVi<35 m. L/m 2 Mohty 2012 Cath (780 pts)

Impact of AVR on Survival in Patients with Paradoxical Low-Flow, Low-Gradient AS Clavel MA

Impact of AVR on Survival in Patients with Paradoxical Low-Flow, Low-Gradient AS Clavel MA JACC in press Tarantini et al. Ann Thorac Surg, 91: 1808 – 15, 2011 Clavel et al. JACC 2012

Results KM mortality for LF vs NF ITT - Cohorts A & B 70%

Results KM mortality for LF vs NF ITT - Cohorts A & B 70% 46. 1% 30% 33. 9% 20% 0% 0 4 8 16 20 24 Months Numbers at Risk 530 441 12 422 368 342 336 317 LF LEF LG NF LEF NG 225 304 282 274 235 239 8 12 16 20 128 179 119 162 24 177 214 154 213 142 193 100 134 ITT - Cohorts A & B 70% HR: 0. 97 [95% CI: 0. 65, 1. 44] Log-Rank p= 0. 886 LF LEF LG LF LEF NG 60% 50. 9% 50% 48. 0% 30% 20% 10% 0% 0 308 300 4 Months 40% 10% LF NF 48. 9% 47. 2% 50% HR: 1. 07 [95% CI: 0. 83, 1. 37] Log-Rank p= 0. 616 LF LEF LF NEF Numbers at Risk 2 -Yr Death (%) 60% 80% 70% 60% 50% 40% 30% 20% 10% 0% 0 HR: 1. 52 [95% CI: 1. 24, 1. 87] Log-Rank p= <. 001 LF (Low Flow) NF (Normal Flow) ITT - Cohorts A & B 2 -Yr Death (%) Definitions Low flow (LF) : SVI ≤ 35 m. L/m² Low ejection fraction (LEF): LV EF ≤ EF 50% Low gradient (LG): Mean gradient ≤ gradient 40 mm. Hg 4 8 16 20 24 83 45 76 43 67 33 Months Numbers at Risk LF LEF LG NF LEF NG 12 147 78 115 62 100 54 94 48

Treatment Comparison in LF, LEF, and LG (both cohorts) 2 -Year Death (%) 90

Treatment Comparison in LF, LEF, and LG (both cohorts) 2 -Year Death (%) 90 LF, LEF and LG - A-TAVR LF, LEF and LG - A-Surgery LF, LEF and LG - B-TAVR LF, LEF and LG - B-Std Rx 80 80. 0% 70 60 50 47. 1% 42. 9% 40 37. 1% 30 20 Log Rank P= 0. 001 10 0 0 60 120 180 240 300 360 420 480 540 600 660 720 Time in Days Number At Risk A-TAVR A-Surgery B-TAVR B-Std Rx 56 49 17 25 50 38 15 19 45 36 14 13 39 35 12 10 38 35 11 10 37 32 9 8 35 29 9 5 32 27 9 5

Results Paradoxical LF, NEF, and LG 90% 80% 70% 2 -Year Death (%) log

Results Paradoxical LF, NEF, and LG 90% 80% 70% 2 -Year Death (%) log rank p= 0. 003 LF NEF LG – A - TAVR LF NEF LG – A - Surgery LF NEF LG – B - TAVR LF NEF LG – B - Std Rx 76. 9% 56. 5% 60% 50% 41. 1% 40% 39. 7% 30% 20% 10% 0% 0 60 120 180 240 300 360 420 480 540 600 660 720 Days Numbers at Risk A – TAVR A – Surgery B – TAVR B – Std Rx 43 44 23 29 39 33 38 30 21 22 19 15 34 30 17 10 34 28 15 9 33 27 33 9 29 27 30 6 26 26 29 5 22 23 26 4

2012 ESC/EACTS Guidelines on Management of VHD: Indications for AVR in AS “The newly

2012 ESC/EACTS Guidelines on Management of VHD: Indications for AVR in AS “The newly recognized entity of paradoxical low-flow, lowgradient AS with normal EF requires special attention because of the limited amount of data on the natural history and outcome after surgery” Vahanian et al. EHJ 2012

Potential Causes of Discordance between AVA (e. g. 0. 8) and gradient (e. g.

Potential Causes of Discordance between AVA (e. g. 0. 8) and gradient (e. g. 30) in Pts. With Preserved LVEF Ø Paradoxical low-flow, low-gradient severe AS Ø Measurement errors Ø Small body size Ø Inconsistency in guidelines criteria Minners et al. Eur Heart J, 2008

Case Study #1 REST Peak ΔP: 51 mm. Hg Mean ΔP: 29 mm. Hg

Case Study #1 REST Peak ΔP: 51 mm. Hg Mean ΔP: 29 mm. Hg AVA: 0. 70 cm 2 DSE 15 µg/kg/min Peak ΔP: 94 mm. Hg Mean ΔP: 57 mm. Hg AVA: 0. 75 cm 2

Usefulness of Stress-Echocardiography to Differentiate True vs. Pseudo- Severe Stenosis in Paradoxical, Low-Flow, Low-Gradient

Usefulness of Stress-Echocardiography to Differentiate True vs. Pseudo- Severe Stenosis in Paradoxical, Low-Flow, Low-Gradient AS AVA (cm 2) 51 patients with PLF-LG Peak DSE Proj Rest Q (m. L/s) AVAProj = AVARest + [ΔAVA/ ΔQ]×(250 -QRest) = 0. 71 + [0. 06/ 55]×(250 -165) = 0. 8 cm 2 Clavel et al. JACC Imaging 2012, in press