Clinical Outcome in Patients with Aortic Stenosis
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1 Clinical Outcome in Patients with Aortic Stenosis Is the Prognosis Worse in Patients with Low-Gradient Severe Aortic Stenosis? Yoel Angel BSc, Shemy Carasso MD, Diab Mutlak MD, Jonathan Lessick MD Dsc, Izhak Kehat MD PhD, Doron Aronson MD Shimon A. Reisner MD, Yoram Agmon MD Echocardiography Laboratory and Heart Valves Clinic Rambam Health Care Campus Technion Israel Institute of Technology Haifa IHS 60 th Annual Scientific Meeting Apr , Jerusalem
2 Conflicts of interest none (all coauthors)
3 Background Trans-aortic pressure gradients (ΔP) typically high in pts with - Severe aortic stenosis (AS) and - Preserved left ventricular ejection fraction (LVEF) P occasionally low despite severe AS (per calculated AVA) Low-gradient / low-output, preserved-lvef AS Frequency of low-gradient / low-output preserved-lvef AS - High? 1,2 - Not so high 3 Questionable prognosis 2,4 - Similar to / worse than high-gradient severe AS? 2,5 - Similar to moderate AS? 4 1 Minners J et al, Eur Heart J 2008;29: Hachica Z et al, Circulation 2007;115: Angel Y et al, Israel Heart Society Annual Scientific Meeting Jander N et al, Circulation 2011;123: Clavel MA et al, JACC 2012;60:
4 Objectives Primary objective To determine the survival of pts with AS in relation to - AS severity moderate or severe (per AVA) - ΔP high or low combinations Secondary objective To examine the pattern of referral to aortic valve replacement (AVR) according to AVA / ΔP combinations
5 Methods Patient Population LVEF < 50% excluded n = 1093 TTE exams 3 yr study period: Native aortic valve stenosis (prosthetic valves excluded) AVA 1.5 cm 2 n = 873 TTE exams LVEF 50% Repeat exams excluded (1st exam analyzed) n = 618 patients AVA (1.0 cm 2 ) Mean trans-aortic P (40 mmhg)
6 Methods Data Collection and Statistical Analysis Data sources - Echocardiography laboratory database - Clinical data (baseline) hospital RMC pts (hospitalized during index echo exam) - AVR during follow-up RMC clinical database & inter-institutional database (Clalit Ofek ) - Mortality Ministry of Interior database Statistical methods survival / referral to AVR - Kaplan-Meier (Log-rank statistics) - Multivariate Cox proportional hazards model
7 Results Patient Subgroups by AVA & ΔP (Mean) Concordance 79.9% (AVA / P) n=53 (8.6%) n=191 (30.9%) n=71 (11.5%) Discordance 20.1% n=303 (49.0%) Low-ΔP severe AS 27% of pts with severe AS
8 Results Patient Characteristics by Subgroups AVA / P (n=191) AVA / P (n=71) AVA / P (n=53) AVA / P (n=303) P Age, yrs 76±11 80±10 75±11 76± Male, n (%) 65 (34) 22 (31) 36 (68) 127 (42) <0.001 AVA, cm 2 < ± ± ± ±0.15 <0.001 Mean P, mmhg 60±15 32±5 51±11 23±7 LVEF, % 64±4 64±4 64±4 64± Indexed SV, ml/m ±10 46±8 67±12 51±11 <0.001 CAD, n (%)* 41 (32) 22 (46) 5 (22) 60 (35) Angina pectoris, n (%)* 54 (43) 17 (35) 9 (39) 63 (37) 0.76 Functional class (NYHA)* 2.3± ± ± ± Syncope (per Hx), n (%)* 25 (20) 3 (6) 4 (17) 22 (13) 0.12 Charlson index 3, n (%)* 32 (25) 20 (42) 3 (13) 63 (37) 0.03 ANOVA P value; * Data in hospitalized patients (n=368:127/48/23/170) AVA = aortic valve area; P = pressure gradient; LVEF = left ventricular ejection fraction; SV = stroke volume; CAD = coronary artery disease (previous MI / CABG / PCI); Charlson index 3 = 75% percentile (all pts)
9 Results Overall Survival by AVA / P Subgroups Log-rank P = 0.18 AVA / ΔP 3 AVA / ΔP 4 AVA / ΔP 1 AVA / ΔP 2 Median follow-up = 969 days (25%-75% ) 184 deaths (30%) No. at risk (1) (2) (3) (4)
10 Results Age, Gender Survival Age Gender Age < 78 yrs (n=281) Male (n=250) Age 78 yrs (median) (n=337) Female (n=368) Log-rank P < Log-rank P = 0.29
11 Results Hospitalization, Comorbidity Survival Hospitalization status Charlson comorbidity index Non-hospitalized (n=250) Low (0-1) (n=186) Hospitalized (n=368) Interm (2-3) (n=112) High ( 4) (n=70) Log-rank P < Log-rank P < 0.001
12 Results Hemodynamics Survival (III) Stroke volume (indexed) Valvulo-arterial impedance SVi > 51 ml/m 2 (median) (n=272) VAI < 3.4 mmhg/ml/m 2 (median) (n=149) SVi 51 ml/m 2 (median) (n=261) VAI 3.4 mmhg/ml/m 2 (median) (n=149) SVi 35 ml/m 2 n=25 Log-rank P = 0.06 Log-rank P = 0.16
13 Results Predictors of Mortality Multivariate Cox Regression (Total Study Population) HR 95% CI P Age, per 10 yrs <0.001 Male gender Hospitalized pts <0.001 AVA / ΔP subgroup 0.78 AVA / ΔP AVA / ΔP AVA / ΔP AVA / ΔP reference SVi, per 10 ml/m 2 * VA impedance * Data available in 533 pts (86%) Data available in 298 pts (48%); HR per 1 mmhg/ml*m 2
14 Results Predictors of Mortality Subgroup Analyses HR 95% CI P I. Hospitalized pts (n=368) Age, per 10 yrs <0.001 AVA / ΔP subgroup 0.55 Charlson index <0.001 Low (0-1) reference Intermediate (2-3) High (>=4) II. Severe AS (AVA < 1.0 cm 2 ; n = 262) Age, per 10 yrs <0.001 Hospitalized pts ΔP (vs. ΔP )
15 Results Referral to Aortic Valve Replacement (AVR) All patients n=618; AVR 212 pts (34%) Excluding 71 pts (12%) hospitalized in cardiac surgery n=547; AVR (28%) Log-rank P < (overall) Log-rank P <0.001 P < vs 2,3; 4 vs 2,3 P = vs 3 AVA / ΔP 1 Log-rank P < AVA / ΔP AVA / ΔP 3 AVA / ΔP AVA / ΔP 2 AVA / ΔP AVA / ΔP 4 AVA / ΔP Predictors of referral to AVR: Age, male gender, hospitalization, Charlson index < 4 (multivariate Cox) AVA / ΔP >> AVA / ΔP AVA / ΔP > AVA / ΔP
16 Results Survival with Medical Rx (without AVR) AVA / ΔP AVA / ΔP AVA / ΔP AVA / ΔP Log-rank P = 0.02 Endpoint = death AVR / end of F/U
17 Conclusions The frequency of low-gradient preserved-lvef severe AS appears to be lower than previously reported Patients with low-gradient severe AS (compared to high-gradient AS): - Older - More comorbidity - Less frequently referred to AVR - All-cause mortality is not higher in these pts despite older age, higher comorbidity & lower referral rate to AVR
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19 Backup slides
20 Study Limitations Selection bias (tertiary medical center) Retrospective pt selection (via echocardiography database) - Prospective follow-up (death / AVR) Retrospective collection of clinical & echocardiographic data Clinical data subgroup of hospitalized pts Analysis of all-cause mortality (± cardiac) Limited follow-up duration (intermediate-term survival)
21 Charlson Weighted Index of Comorbidity 1 point 2 Points 3 Points 6 points Myocardial Infarction Hemiplegia Mod. / Sev. Liver Disease Congestive Heart Disease Diabetes (no end organ damage) CVA Connective Tissue Disease Dementia Chronic Pulmonary Disease Ulcer Disease Mild Liver Disease Peripheral Vascular Disease Mod. / Sev. Renal Disease * DM + end organ damage Any Tumor Leukemia Lymphoma Metastatic Solid Tumor AIDS * Cr > 2 or diagnosis of chronic renal disease Charlson M et al, J Chron Dis 1987: 40(5);
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