Intervention Versus Observation in Symptomatic Patients With Normal Flow Low Gradient Severe Aortic Stenosis.

OBJECTIVES

The purpose of this study was to describe patients with severe symptomatic aortic stenosis with normal flow and low gradients and determine whether they benefit from intervention.

BACKGROUND

Severe symptomatic aortic stenosis is a progressive disease with high mortality. Although surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR) are indicated for patients with high gradients (>40 mm Hg) or low gradients due to low flow, the approach for patients with normal flow and low gradients is poorly defined.

METHODS

Consecutive adult patients who underwent echocardiography between 2012 and 2015 at Tel-Aviv Medical Center and had an aortic valve area of ≤1.0 cm2, a mean gradient of <40 mm Hg, a stroke volume index of >35 ml/m2, and symptoms formed the study group. Patients designated for intervention (SAVR or TAVR) had their procedure within 6 months of the echocardiogram; the others were treated conservatively. The endpoints were all-cause mortality and cardiac-related mortality.

RESULTS

During the study period, 1,358 patients with an aortic valve area of ≤1.0 cm2 and symptoms were identified; 34% of these had normal flow and low gradient aortic stenosis and 303 were included. After mean follow-up of 652 days, 60 patients (20%) had died, with overall mortality rates of 28%, 10%, and 12% for conservatively treated, TAVR, and SAVR patients, respectively (p < 0.001). Using Cox regression with adjustment for other variables, TAVR was associated with improved survival versus conservative treatment (hazard ratio [HR]: 0.49; 95% confidence interval [CI]: 0.26 to 0.93; p = 0.03), and lower cardiac mortality (HR: 0.30; 95% CI: 0.10 to 0.74; p = 0.007) with no significant difference for SAVR versus TAVR. After propensity score matching of TAVR and conservatively treated patients, 25 of 94 (28%) conservatively treated and 10 of 94 (12%) TAVR patients had died (p = 0.016). In the matched cohort, Cox regression showed that TAVR had a significant association with improved survival (HR: 0.42; 95% CI: 0.20 to 0.86; p = 0.03).

CONCLUSIONS

Symptomatic patients with an aortic valve area of ≤1.0 cm2, normal flow, and low gradient may benefit from intervention as opposed to conservative treatment.