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מחלות המסתם האאורטלי דן גילון 23.10.2013. 3 – D Aortic Valve. Aortic Stenosis Incidence. Most frequent valvular heart disease in Europe and the U.S. Most frequent heart disease after hypertension and CAD (calcific AS) Incidence in the population of advanced age about 2 - 9%
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מחלות המסתם האאורטלידן גילון23.10.2013
Aortic StenosisIncidence • Most frequent valvular heart disease in Europe and the U.S. • Most frequent heart disease after hypertension and CAD (calcific AS) • Incidence in the population of advanced age about 2 - 9% • Aortic valve surgery is the only established treatment
Euro Heart Survey on Valvular Heart Disease Single Native Valve Disease Courtesy of Alec Vahanian
Aortic ValveHistory Leonardo Da Vinci; 15th century
Ossification Mohler ER et al. Circulation 2001;103:1522-8 Medical Therapy for Aortic Stenosis Background • Mineralization close to areas of inflammation • Formation of mature lamellar bone Calcification Otto CM, O‘Brien K. Heart 2001;85:601-2
Aortic StenosisCommon features with atherosclerosis Newby, D E et al. Heart 2006;92:729-734
Aortic StenosisCardiovascular Features of a Patient With Familial Hypercholesterolemia Atheromatous plaques Clotted Circumflex artery Rajamannan, N. M. et al. N Engl J Med 2003;349:717-718
Men Women Aortic SclerosisIncidence 1.0 0.8 0.6 0.4 0.2 0.0 Probability of aortic valve sclerosis 50 60 70 80 90 Age (yrs) Agmon Y et al. J Am Coll Cardiol 2001;38:827-34
100 80 60 40 20 0 No Aortic sclerosis (n=212) Mild Aortic sclerosis (n=149) Moderate-severe Aortic sclerosis (n=54) 0 40 80 120 160 200 240 280 320 360 Aortic SclerosisAssociation with Mortality Patients presenting to the Emergency Room with Chest pain Event-free survival (%) P < 0.002 Days Chandra HR et al. J Am Coll Cardiol 2004;43:169-175
Aortic SclerosisAssociation with Morbidity Hazard Ratio (95% CI) p-value 0 1 2 3 4 Aortic Sclerosis 1.37 (0.98-1.78) 0.139 Age (years) 1.03 (1.001-1.06) 0.04 Heart Failure 2.15 (1.48-2.82) 0.025 CRP tertiles 2.20 (1.71-2.20) 0.001 MI at admission 2.77 (2.0-3.53) 0.008 CAD3.23(2.47-3.99) 0.003 Chandra HR et al. J Am Coll Cardiol;43:169-175
100 90 80 70 60 50 40 30 20 10 0 general population patients with mild-to-moderate AS 80% increase in mortality! 0 1 2 3 4 5 6 7 Mild-to-Moderate AS Mortality - Comparison with normal population Survival (%) increase of both, cardiac and non-cardiac mortality P < 0.005 Rosenhek et al. Eur Heart J 2004;25:199-205 years
2.5 - 3.0 m/s 3.0 - 4.0 m/s > 4.0 m/s < 25 mmHg 25 - 50 > 50 mmHg > 1.5 cm2 1.5 - 0.8 cm2 < 0.8 cm2 Aortic Stenosis a Progressive DiseaseSeverity of Disease Mild AS Moderate AS Severe AS peak * Velocity mean * Gradient Valve Area * In the presence of normal flow conditions
100 80 60 40 20 0 Onset of severe symptoms failure syncope angina 2 3 5 Average survival (yrs) Average age of death 40 50 60 63 70 80 Severe Aortic Stenosis Prognosis of Symptomatic Patients Latent period (increasing obstruction, Myocardial overload) Survival (%) Age (yrs) Ross, Braunwald Circulation 1968
Patients having undergone AVR because of severe AS (n=314) Patients with severe AS who refused surgery (n=35) Severe Symptomatic Aortic Stenosis Surgery vs. Conservative 100 80 60 40 20 0 Cumulative survival (%) P<0.0001 2 4 6 8 10 Horstkotte, Loogen. Eur Heart J 1988;9:57-64 Time (yrs)
AV-Vel < 3 m/s AV-Vel 3-4 m/s AV-Vel > 4 m/s Asymptomatic Aortic Stenosis Event-free Survival (%) 0 12 24 36 48 60 months Otto CM, et al. Circulation 95:2262, 1997
General Population Patients with Aortic Stenosis Asymptomatic Severe Aortic Stenosis Wait for Symptoms Strategy 100 90 80 70 60 50 40 30 20 10 0 Overall Survival among 126 Patients with Asymptomatic but Severe Aortic Stenosis, as Compared with Age- and Sex-Matched Persons in the General Population P = n.s. 0 1 2 3 4 5 Rosenhek, R. et al. N Engl J Med 2000;343:611-617
Asymptomatic Severe Aortic Stenosis Incidence of Sudden Death Pellikka 270 65 PV ≥ 4.0 11 2005
STS Cardiac Surgery Database 1997 Preoperative Risk Variables Aortic Valve Replacement N = 9095 Mortality 3.6% Operative Mortality (%) NYHA Class
STS U.S. Cardiac Surgery Database 1997 Preoperative Risk Variables Aortic Valve Replacement N = 9095 Operative Mortality (%) Urgency
135 patients • 2 patients had a sudden death before catheterization • 16 deaths (12 of these sudden) on the waiting list (up to 8 mths). Matthews, AW et al. Br Heart J 1974;36:101-103 • 99 patients consecutive prospectively enrolled patients. • Average waiting time: 6 months • 7 deaths on the waiting list Lund, O et al. Thorac Cardiovasc Surgeon 1996;44:289-295 Severe Aortic Stenosis Risk of Death on the Waiting List Mortality on the waiting list 18%/yr Mortality on the waiting list 14%/yr
Asymptomatic Severe Aortic Stenosis Wait for Symptoms Strategy Necessity for Risk Stratification
AS: CLINICAL MANIFESTATIONS • Angina • Syncope • Exertional Dyspnea / CHF • GI Bleeding • Atrial Fibrillation • SBE
Calcified AOV RCC In the middle of calcification LV RV LV LCC R AOV AO root NCC LVOT LA LA Transission AML to annulus
AS: MANAGEMENT • Medical • Surgical • Valvuloplasty • PCI
Therapy for AS: previous trials • The association between TC and progression of native AS (assessed by Doppler) in a community-based study of 156 patients (age 77 ± 12 years; 90 men). • Thirty-eight patients received statin treatment during follow-up • Progression of AS is not correlated with TC. Statins are associated with slower progression. • (Bellamy et al. JACC 2002).
AVR: Surgical Risk • Operative Mortality: • AVR 4.3% • AVR+CABG 8% • AVR+additional valve 7.4% • AVR+aortic aneurism repair 9.7% • Risk factors: • NYHA class • LVF • Age • IHD • Arrhythmia • AR • Cummulative 10 year survival 85%
AS: BALLOON VALVULOPLASTY • Mortality (Critically ill patients): • Procedure: 3% • 30 day: 14% • 1 year: 45 % • Serious complications (AR, MI, Perf): 6% • Restenosis at 6 m: 50%
Self-Expanding Multi-level Support Frame Diamond cell configuration Nitinol: memory shaped/no recoil Multi-level design incorporates three different areas of radial and hoop strength • Low radial force area orients the system • Constrained area avoids coronaries and features supra-annularvalve leaflets • High radial force provides secure anchoring and constant force mitigates paravalvular leak Radiopaque
Porcine Pericardial Tissue Valve • Specifically designed for transcatheter delivery • Single layer porcine pericardium • Tri-leaflet configuration • Tissue valve sutured to frame • Standard tissue fixation techniques • 200M cycle AWT testing completed • Supra-annular valvefunction • Intra-annular implantation and sealing skirt