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DOI: 10.1161/CIRCULATIONAHA.112.001290

Predictors of Mortality and Outcomes of Therapy in Low Flow Severe Aortic

Stenosis: A PARTNER Trial Analysis

Running title:Herrmann et al.; Predictors of Outcomes in Low Flow Severe Aortic Stenosis

Howard C. Herrmann, MD1; Philippe Pibarot, PhD

2; Irene Hueter, PhD

3; Zachary M. Gertz, MD

4;

William J. Stewart, MD5; Samir Kapadia, MD

5; E. Murat Tuzcu, MD

5; Vasilis Babaliaros, MD

6;

Vinod Thourani, MD6; Wilson Y. Szeto, MD

1; Joseph E. Bavaria, MD

1; Susheel Kodali, MD

3;

Rebecca T. Hahn, MD

3

; Mathew Williams, MD

3

; D. Craig Miller, MD

7

; Pamela S. Douglas, MD

8

;Martin B. Leon, MD

3

1University of Pennsylvania, Philadelphia, PA;

2Quebec Heart and Lung Institute, Laval

University, Quebec, Canada;3Cardiovascular Research Foundation and Columbia University,

New York, NY;4VCU School of Medicine, Richmond, VA;

5Cleveland Clinic, Cleveland, OH;

6Emory University, Atlanta, GA;

7Stanford University, Palo Alto, California;

8Duke University,

Durham, NC

ebecca T. Hahn, MD ; Mathew Williams, MD ; D. Craig Miller, MD ; Pamela S. , D

Martin B. Leon, MD3

1

ity o ennsylvania, Philadelphia, ;

Quebec Heart a ung Institute, Laval

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Abstract:

BackgroundThe prognosis and treatment of patients with low flow (LF) severe aortic stenosis

(AS) is controversial.

Methods and ResultsThe PARTNER trial randomized patients with severe AS to medical

management (MM) vs transcatheter (TAVR) aortic valve replacement ("inoperable" cohort) and

surgery (SAVR) vs TAVR (high risk cohort). Among 971 patients with evaluable

echocardiograms (92%), LF (stroke volume index (SVI) 35 ml/m2) was observed in 530 (55%),

LF and low ejection fraction (


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Aortic valve replacement (AVR) is indicated for patients with severe aortic stenosis (AS)

associated with either symptoms or left ventricular (LV) dysfunction1, 2

. Severe AS is generally

defined as an aortic valve area < 1.0 cm2 and a mean transvalvular gradient of > 40 mmHg.

However, many patients with symptomatic and severe AS may have lower gradients due to left

ventricular systolic dysfunction (so called low flow, low ejection fraction), high afterload and

pronounced LV concentric remodeling (paradoxical low flow, normal ejection fraction), and

due to errors or assumptions inherent in the measurement of gradient and valve area3-7

. These

patients have a similar or worse prognosis than those with classic AS, both with and without

surgery6-14

. However, little is known about the prognostic value of low flow independent of

gradient and ejection fraction, and its treatment.

Transcatheter aortic valve replacement (TAVR) has recently emerged as an alternative to

open surgical AVR (SAVR) in both inoperable and high-risk patients with severe AS15-18

. In

order to better understand the implications of low flow in severe aortic stenosis, we utilized core

echocardiographic laboratory data to examine the prognostic implications of low flow (LF), low

radient and ejection fraction, and its treatment.

Transcatheter aortic valve replacement (TAVR) has recently emerged as an alternative to

pe A (SAVR) in both inoperabl

e high-risk pat nt h severe AS15-18

. In

rd r to better

u er m i

ns f ow fl

o i s

e a

orticste

n

i , e u li c re

o i p icla o

a or

o

e p o

n c l s l w w( l

w


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severe AS. Inclusion criteria for this trial included a site-measured echocardiographic aortic

valve area of < 0.8 cm2 (or indexed AVA 40 mmHg or a peak aortic-jet velocity > 4.0 m/s (64 mmHg). Important exclusion

criteria included substantial coronary artery disease requiring revascularization, EF < 20%, or

severe (4+) aortic (AR) or mitral regurgitation (MR). Patients were treated with the Edwards

SAPIEN balloon-expandable bovine pericardial heart valve system (Edwards Lifesciences). The

primary end point for the study (both cohorts) was all-cause mortality at 1 year or more, but

follow-up has continued allowing for subsequent analyses with adjudicated events17, 18

. All

echocardiograms were analyzed in an independent core laboratory19

. The database for the study

is maintained at the Cardiovascular Research Foundation (New York, NY), where independent

statistical analyses can be requested by investigators.

In this analysis, patients with evaluable echocardiograms were classified into 2 groups

based on baseline echocardiographic stroke volume index of < 35 ml/m2 (low flow, LF) or

normal flow (NF)2, 4

. The LF group was then further divided based on EF < 50% (LF LEF) or

s maintained at the Cardiovascular Research

Foundation (New York, NY), whe

re i

d t

tatistical analyses can be requested by investigators.

a sis, patients with evaluable h cardiograms er ssified into 2 groups

as d on baseli e

ec c

r ra

i tr kev lu in

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