Saudi Heart Association. Raising Standards through Education and Training

Transcription

1 Saudi Heart Association Raising Standards through Education and Training

2 25th Annual Meeting EACTS Lisbon, Oc ctober 2011 WWW EA WWW. ACTS ORG ACTS.ORG

3 Clinical decision making in case of Aortic valve stenosis The Tim me Has Come for a SYNTAX like Trial A.P. Kappetein, S. Head, N. Piazza, M v Geldorp, A. Bogers, H. Takkenberg Dept Cardio-thoracic surgery, Rotterdam, The Netherlands Munich, Germany

4 The prevalence of Aortic Stenosis 3% at the age of 75 years 8% attheageof85the age years

5 Annual valve replacements Prevalence of Aortic Stenosis 2008 Europea n Union 20% needing AVR: potential patients today 4% Prevalence AoS European Union population > 65 years M 77 M

6 Why is the Decision to Operate or Not to Operat te so Difficult?

7 Case Mrs Brown year-old female evaluated for a heart murmur 2. Increasing dyspnea 3. Some difficulty with bathing or showering 4. Shopping done by daughter 5. Risk factors: 1. CABG in history (reoperation!);open LIMA 2. Mild COPD

8 Mrs Brown Physical examination 65 kg, 1.70 meter; BMI < 25 Blood pressure 140/70 mm Hg; Pulse 80 bpm Respiration, 17 breaths per minute Creatinine 140 3/6 late-peaking systolic ejection murmur that radiates to the neck

9 Mrs Brown Echoca ardiogram 1. Echocardiogram: decreased systolic function, heavily calcified aortic valve 2. Peak Doppler transvalvularr gradient 80 mm Hg, mean gradient of 60 mm Hg 3. Calculated valve area is 0.6 cm2 4. LV function: Moderate

10 Mrs Brown Diagnosis: Severe symptomatic aortic stenosis Treatment? Medically (including balloon Transcatheter heart valve im mplantation Surgical valve implantation valvuloplasty?) l l

11 Mrs Brown Logistic Euroscore : 50% STS score : 12%

12 Frailty and Survival

13 Patient selection: include frailty Patient A vs. Patient B Same age and predicted risk One passes the eyeball test one does not Photos courtesy of Michael J. Mack, MD. Medical City Dallas. Slide adapted from Michael J. Mack, MD. Medical City Dallas.

14 More general score for fra ilty? Lee,JAMA 2006; 295: c statistic of 0. 82

15 4 year mortality in old adults according to age and risk score Variable Age (years) 60 64: 64: 65 69: 70 74: 75 79: 80 84: 85: Sex Male Comorbidities Body mass index < 25 Diabetes Cancer, excluding minor skin cancers Chronic lung disease limiting usual activities 1 point 2 points 3 points 4 points 5 points 7 points 2 points 1 point 1 point 2 points 2 points

16 4 year mortality in old adults according to age and risk score Congestive heart failure Current smoking 2 points 2 points Functional evaluations Do you have any difficulty with bathing or showering? * Do you have any difficulty with managing your money Paying your bills and keeping track of expenses? * Do you have any difficulty with walking several blocks? * Do you have any difficulty with pulling or pushing large objects like a living room chair? * 2 points 2 points 2 points 1 point * Because of a health or memory problem Lee,JAMA 2006; 295: 801 8

17 88 year old female with ih AoS S, with ih co morbidities i Lee Score 13 4 year mortality 60%

18 TAVI versus Medical Treatment?

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20 Patient Chara acteristics -1 Characteristic TAVI n=179 Standard Rx n=179 P value Age - yr 83.1 ± ± Male sex (%) STS Score 11.2 ± ± Logistic EuroSCORE 26.4 ± ± NYHA I or II (%) 7.8 III or IV (%) 92.2 CAD (%) 67.6 Prior MI (%) 18.6 Prior CABG (%) 37.4 Prior PCI (%) 30.5 Prior BAV (%) 16.2 CVD (%)

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22 Procedural TAVI (179 patients) 6 (3.4%) pts did not receive TAV VI During TAVI (first 24 hours) Outcomes 2 (1.1%) deaths 3 (1.7%) major strokes 1 (0.6%) valve embolization 2 (1.1%) pts with multiple ( 2) val lve implants 30 days mortality: 6.4% (n=11) pts receiving TAVI died

23 Procedural Standard Rx (179 patients) BAV performed in 114 (63.7%) pts 30 days and an additional 36 ( %) pts > 30 days after r andomization (total BAV = 83.8% 8% pts) Despite inoperable status: 12 (6.7%) pts received AVR 5 (2.8%) received LV - desc Ao conduit + AVR 4 (2.2%) received TAVI outside US 1-year mortality of pts receiving AVR, AVR-conduit, or TAVI (outside US): AVR - 33% AVR + conduit - 80% TAVI (outside US) -0% Outcomes

24 All Cause Mortality lity (%) se mortal All-caus Standard Rx TAVI at 1 yr = 20.0% NNT = 5.0 pts 50.7% 30.7% Months Numbers at Risk TAVI Standard Rx

25 Clinical Outcomes at 30 D ays & 1 Year Outcome 30 Days n= =179 1 Year n=179 TAVI Standard Rx P-value Vascular complications All (%) < <.0001 Major (%) < <.0001 Acute kidney injury Creatinine >3 mg/dl (%) RRT (%) Bleeding - major (%) < Cardiac re-intervention BAV (%) <.0001 Re-TAVI (%) 1.7 na 1.7 na AVR (%) <.0001 Endocarditis (%) Arrhythmias New atrial a fibrillation (%) New pacemaker (%) TAVI Standard Rx P-value

26 NYHA and mortality

27 Intermediate risk patients?

28 Case Mr Richard year-old man is evaluated f or a heart murmur 2. Walks 2 km per day 3. Wife notes decreased physical activity over the past year 4. Risk factors: none 1. No diabetes 2. No COPD

29 Mr Richard Physical examination kg, 1.80 meter 2. Blood pressure 120/70 mm Hg; 3. Pulse 80 bpm 4. Respiration, 13 breaths per mi nute 5. Creatinine /6 systolic ejection murmur that radiates to the neck

30 Mr R Echocardiogram 1. Echocardiogram: normal systolic function, heavily calcified aortic valve 2. PeakDoppler transvalvular gradient 64 mm Hg, mean gradient of 50 mm Hg 3. Calculated valve area is 0.8 cm2

31 Surgery or percutaneous valve?

32 Information needed: 1. What is average life expectancy according to age and sex? 2. What is the survival with medical treatment (natural history)? 3. Can we predict surgical risk? 4. Can we bring life expectancy back to normal? 5. Do we improve quality of life?

33 Years Life expectancy average men / women > 80 years 4 Men Women Age

34 What is the life expectancy with medical treatment (na atural history)?

35 Severe Symptom matic Patients Require Urge nt Attention Surgical intervention should be performed promptly once even minor symptoms occur 1 1 C.M. Otto. Valve Disease: Timing of Aortic Valve Surgery. Heart 2000 Chart:: Ross J Jr, Braunwald E. Aortic stenosis. Circulation. 1968;38 (Suppl 1):61-7.

36 179 patients with symptomatic severe aortic stenosis 90% 69% P=0.01

37 80 year old man with ih AoS, no comorbidities i Lee Score 9 4 year mortality 40%

38 Can we predict Operative risk?

39 Different risk scorings Low risk patient High risk patient 75 year old male with ejectio on fraction 55% and no other comorbidities 85 year old female with ejection fraction 30%, renal dysfunction and pulmonary hypertension Nashef et al. EuroSCORE STS online calculator, dataset 2.61 Nowicki et al. NNE Jin et al. PHS Rankin et al. STS score Hannan et al. NY State 4.3% 1.0% 1.3% 1.0% 3.4% 1.8% 59.8% 15.4% 4.3% 6.6% 7.2% 8.5% Kuduvalli et al. Multicenter 2.6% 27.4%

40 Outcome of Octogenarians after sa AVR or savr combined with CABG Reference Number of patients Ferrari (2010) 124 Leontyev (2009) 282 de Vincentis (2008) 345 Gulbins (2008) 236 Filsoufi (2008) 231 Melby (2007) 245 Kolh (2007) 220 Bose (2007) 68 Langanay (2006) 442 Patient characteristics In hospital mortality > 80 years (Isolated AVR) 5.4% > 80 years (Isolated AVR) 7.8% > 80 years (70% CABG) 7.5% > 80 years (91% CABG) 9.3% >80 years (48% CABG) 5.2% > 80 years (57% CABG) 9.0% > 80 years (26% CABG) 9.0% > 80 years (46% CABG) 13% > 80 years (19% CABG) 7.5% 9 studies, N= 2193 patients Ra Ra nge: 5.2to 13% Weighted average: 8.9%

41 Survival after surgical AVR?

42 Life expectancy > 80 year old AVR+CABG Life Exp pectanc cy (year rs) Average Dutch Male AVR + CABG Bioprosthesis Age

43 80 year old man with ih AoS, no comorbidities i Lee Score 9 4 year mortality 50%

44 TAVI Pandemania

45 Relative European numbers Aortic Tissue Valve Procedures TAVI SAVR 2% 10% 25% 28% # of procedur res Germany, France, Italy, UK,

46 SURTAVI trial

47 Basic Principles for Randomized Trial Goals To define the patient to be treated by TAVI To define the patient to be treated by SAVR All-comers study No highly selected population Heart Team approach Surgeon Interventional Cardiologist Nested registries Define characteristics of non randomized patients

48 Intermediate risk patients with severe AS 70 yrs of age 2 4 risk factors 75 yrsof age 1 3 risk factors 80 yrs of age 0 2 risk factors Risk factors: Coronary artery disease requiring revascularization Frailty Left Ventricular dysfunction (< 35%) Neurological ldysfunction (with hfunctional li mpairment Pulmonary disease (FEV1 / VC below 70% of normal) Peripheral vascular disease Renal disease (Creatinine > 200, chronic dialysis) Redo cardiac surgery Pulmonary hypertension (> 60mmHg at most recent measurement) Poor Metabolic state (high bilirubine, low albumin, Diabetes, Cachexia

49 Euroscore /STS score versus age

50 Study design Primary endpoint event rate of 20% in each treatment arm non-inferiority of TAVI to SAVR for the primary endpoint Hazard ratio of 1.3 Median follow-up of 2 years

51 Intermediate risk population

52 Take Hom e Message Rapid expansion percutaneous heart va alves Percutaneous valve implantation in intermediate risk patient an alternative? The only way to find out is a randomized trial

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