Therapeutic decisions for patients with symptomatic severe aortic stenosis:

room for improvement?

Results of the Aortic VAlve RIJNmond study

M.W.A. van Geldorp1, H.J. Heuvelman1, B. Arabkhani1, M. van Gameren1, A.P. Kappetein1, J.J.V. Busschbach2, T.W. Galema3, J.J.M. Takkenberg1, A.J.J.C. Bogers1

1Dept. of Cardiothoracic Surgery, 2dept. of Psychology and Psychotherapy,

3Dept. of Cardiology Erasmus University Medical Center, Rotterdam

Aortic Valve Surgery: Present and FutureAMC, 12-05-2011

Background Prevalence of aortic stenosis:

2.5% @ 70 yrs, 8% @ 80 yrs

Progression: PAG +6 mmHg/yr; AVA -0.1 cm2/yr

Aortic stenosis is rising health problem (elderly)

Hospitalization for Heart Valve disease The Netherlands 1995 - 2004

80-85 years

85-90 years

> 90 years

Aortic stenosis as cause of death (NL)

4

0

50

100

150

200

250

300

350

1996 1998 2000 2002 2004 2006 2008 2010

65-70 yrs

70-75 yrs

75-80 yrs

80-85 yrs

85-90 yrs

90-95 yrs

www.cbs.nl

Aortic Stenosis as cause of death The Netherlands (1996 – 2006)

Literature

59 68 70

40

41 32 30

60

0%

25%

50%

75%

100%

Bouma 1999 Iung 2004 Pellikka 2005 Charlson 2006

AVR

Unoperated

Symptomatic patients with severe aortic stenosis

Background Prevalence of aortic stenosis:

2.5% @ 70 yrs, 8 % @ 80 yrs

Progression: PAG +6 mmHg/yr; AVA -0.1 cm2/yr

Aortic stenosis is rising health problem (elderly)

Controversy between ACC/AHA guidelines and recent literature

Diagnosis-treatment gap

New techniques to treat the stenotic aortic valve: TAVI

Why are so many (elderly) symptomatic patients denied surgery?

‘Natural history’?

Expected life gain after surgery? Quality of life?

Objectives

Symptomatic

AVR No AVR

n=179

n=2?

n=76 (42%) n=101 (56%)

Follow-up: 17 months

Age (yrs) Male Mean Log EuroSCORE Log EuroSCORE >15%

AVR67.9 (22-89)49%7.8% (1.5-56)4%

No AVR73.3 (35-92)51%11.3% (1.5-45) 18%

Pilot study

Patient preference ‘High risk’ ‘Mild symptoms’ / ‘asymptomatic’ Aortic stenosis ‘non-severe’ Decision pending Reason not clearly documented

10% 33% 19% 14% 5% 20%

Why?

Age (yrs) Mean log EuroSCORE Log EuroSCORE >15%

No AVR73

11.3%18%

Pilot

Symptomatic patients: medical treatment in 56%, AVR in 42% (!)

59 68 70

40 42

41 32 30

60 56

0%

25%

50%

75%

100%

Bouma 1999 Iung 2004 Pellikka 2005 Charlson 2006 v Geldorp 2009

AVR

Unoperated

Symptomatic patients with severe AS

AVARIJN study (Aortic VAlve RIJNmond)

Methods

Inclusion of patients with severe AS in the outpatient clinics in the wider Rotterdam area

Inclusion period: July 2006-April 2009

Baseline: -Patient data, functional status, quality of life (SF-36, EuroQol) -Echocardiography; tissue doppler imaging -Nt-proBNP -Exercise testing (asymptomatic patients only)

Follow-up: 6 months, 1- and 2-year

Participantsn=191

Symptomaticn=132

Asymptomaticn=59

AVRn=70

Conservativen=62

Severe ASn=459

Refusedn=268

Conservativen=38

AVRn=21

(12 asympt)

mean f-up 1.7 yrs mean f-up 1.4 yrs

Flow chart AVARIJN

Patient characteristics at baseline

All N=191

Asymptomatic N=59

Symptomatic N=132

P-value

Age (yrs) 70.6 ± 11.4 68.7 ± 10.5 71.5 ± 11.7 0.034 Male gender (%) 62 76 56 0.008 Previous valve surgery (%) 1 0 2 0.343 Previous CABG (%) 6 3 8 0.272 History of: Only dyspnea (%) 31.9 46.2 Only angina (%) 3.1 4.5 Only syncope (%) 2.6 3.8 Combination (%) 62.4 45.5 History of smoking (%) 61 71 56 0.049 Current smoking (%) 18 19 17 0.839 Hypertension (%) 52 49 54 0.554 Diabetes (%) 20 22 19 0.622 Dislipidemia (%) 49 47 49 0.820 COPD (%) 17 10 20 0.083 PAD (%) 13 7 15 0.108 History of MI (%) 13 8 15 0.207 Previous CABG (%) CVA (%) 19 20 18 0.725 NYHA class I+II (%) 69 100 55 <0.001 III+IV (%) 31 0 45 <0.001 Body mass index 27.5 ± 4.4 27.1 ± 3.8 27.7 ± 4.7 0.711 Body surface area (m2) 1.90 ± 0.20 1.94 ± 0.20 1.88 ± 0.20 0.107 BP systolic (mmHg) 142 ± 27 146 ± 23 141 ± 28 0.181 BP diastolic (mmHg) 79 ± 12 81 ± 9 77 ± 13 0.050 ECG Sinus rhythm (%) 90 91 90 0.794 LVH (%) 27 24 28 0.531 Old infarction (%) 21 21 21 0.935 Ischemia (%) 15 12 17 0.418 Cycle ergometry Number of patients 50 47 3 Positive outcome (patients) 16 15 1 0.960 NT-proBNP (pmol/L) 160 ± 336 122 ± 356 177 ± 327 <0.001 Medication (%) No medication 14 22 10 0.024 Statins 42 41 43 0.747 Antiplatelets 39 29 44 0.049 Betablocker 31 24 29 0.127 Diuretics 26 20 29 0.221 Follow-up (years) 1.56 ± 0.71 1.79 ± 0.65 1.46 ± 0.72 0.004

AllN=191

AsymptomaticN=59

SymptomaticN=132

P-value

Vmax (m/s) 4.2 (3.7-4.7) 4.2 (3.7-4.7) 4.3 (3.7-4.8) 0.672PAG (mmHg) 72 (54-89) 69 (54-84) 73 (56-91) 0.504MAG (mmHg) 42 (33-51) 40 (33-48) 43 (33-52) 0.419AVA (cm2) 0.74 (0.59-0.91) 0.80 (0.63-0.96) 0.72 (0.54-0.85) 0.026

AoR ≥ grade 2 (%) 17 14 18 0.494MR ≥ grade 2 (%) 11 4 15 0.027TR ≥ grade 2 (%) 8 4 11 0.359

Echocardiography parameters at baseline

93%

76%

58%

41%

Freedom from AVR

Results SF 36v2

Results SF 36v2

Results SF 36v2 Quality of life according to symptomatic status

Results SF 36v2 Quality of life according to symptomatic status

Results SF 36v2 Quality of life according to symptomatic status

Results SF 36v2 Quality of life according to symptomatic status

Results General dutch population 41-60yrs vs symptomatic patients 41-60yrs

Results General dutch population 61-70yrs vs symptomatic patients 61-70yrs

Results General dutch population >70yrs vs symptomatic patients >70yrs

Results Symptomatic patients treated medically: baseline vs 2yr f-up

Results Symptomatic patients treated surgically: before AVR vs 1yr after AVR

Conclusions

Daily practice very different from guidelines: undertreatment?• Possible overestimation of operative risk• Symptoms unrecognized or unaccounted for• Misclassification of haemodynamic severity• Patient preference

Even mild symptoms have major impact on physical and emotional/social QoL, regardless of age. Disease burden compared to general population is large!

QoL improves after AVR (in selected patients)

room for improvement!!• Accurate patient assessment (“listen to the patient, look at the

valve”, C.M. Otto)

• Heart team

• QOL survey standard armamentarium