Log in to MyACC
Aortic Stentless versus Stented valve assessed by Echocardiography Randomized Trial - ASSERT Stentless vs Stented Valve
Description:
The goal of the trial was to evaluate aortic stentless versus stented valves on left ventricular mass among patients with severe aortic stenosis.
Study Design
Patients Screened: 234
Patients Enrolled: 190
Mean Follow Up: 12 months
Mean Patient Age: Mean age 70 years
Female: 45
Patient Populations:
Severe aortic stenosis, annulus size was ≤25 mm evaluated using the Freestyle valve sizer, considered suitable for either valve per the surgeons evaluation.
Exclusions:
Age <40 years,="" previous="" surgery="" on="" the="" aortic="" valve,="" need="" for="" aortic="" root="" replacement,="" need="" for="" additional="" valve="" repair="" or="" replacement,="" acute="" infective="" endocarditis,="" aortic="" valve="" disease="" with="" predominant="" aortic="" regurgitation,="" cerebrovascular="" accident="" in="" prior="" 6="" months,="" poor="" quality="" echocardiogram,="" inability="" to="" comply="" with="" follow-up="" procedures.="" years,="" previous="" surgery="" on="" the="" aortic="" valve,="" need="" for="" aortic="" root="" replacement,="" need="" for="" additional="" valve="" repair="" or="" replacement,="" acute="" infective="" endocarditis,="" aortic="" valve="" disease="" with="" predominant="" aortic="" regurgitation,="" cerebrovascular="" accident="" in="" prior="" 6="" months,="" poor="" quality="" echocardiogram,="" inability="" to="" comply="" with="" follow-up="">
Primary Endpoints:
Change in left ventricular mass index (LVMI) measured by transthoracic echocardiography at 6 months
Secondary Endpoints:
LVMI at 12 months, LV function, NYHA class, 6-minute walk test, quality of life, and clinical events up to 12 months.
Drug/Procedures Used:
Prior to surgery for aortic valve replacement, patients were consented for enrollment into the trial. Once the surgeon determined that the anatomy was suitable for either valve, patients were randomized to either stentless valve (n=93) or stented valve (n=97). Patients underwent echocardiography at baseline, 6 months, and 12 months.
Principal Findings:
Among the 93 patients randomized to the stentless valve group, 89 received the stentless valve; among the 97 patients randomized to the stented valve, 94 received the stented valve. Baseline characteristics were well balanced between groups, with the exception of cross-clamp time, which was longer in the stentless group (100 minutes vs 70 minutes, p<0.001), as="" was="" cardiopulmonary="" bypass="" time="" (133="" min="" vs="" 99="" min,=""><0.001). cabg="" surgery="" was="" performed="" concomitantly="" in="" 39%="" of="">
LVMI at 6 months decreased in both groups from baseline to 6 months, but there was no difference between groups in the primary endpoint of change in LVMI (49 g/m2 for stented vs 36 g/m2 for stentless, p=0.11). There was no change from baseline to 6 months in ejection fraction in either group (71% at 6 months in stent group and 70% in stentless group). Effective orifice area (EOA) at 6 months was larger in the stentless valve group (1.03 cm2/m2 for stentless vs 0.78 cm2/m2 for stented, p<0.001). reduction="" in="" peak="" aortic="" velocity="" was="" also="" greater="" in="" the="" stentless="" valve="" group="" (2.2="" cm2/s="" vs="" 1.8="" cm2/s,=""><0.001).>
Interpretation:
Among patients with severe aortic stenosis, aortic valve replacement with a stentless valve was not associated with a difference in change in left ventricular mass index at 6 months compared with aortic valve replacement with a stented valve.
Prior randomized trials have been mixed with regard to the effect of stented vs stentless valves on LVMI. While there was no difference in change in LVMI in the present study, stentless valves were associated with greater increases in effective orifice area and larger improvements in peak flow velocity. The implantantion of stentless valves is more complex, as evidenced by the longer cross-clamp time and longer cardiopulmonary bypass time. Despite these longer times, there was no difference in clinical outcomes, including mortality, which in larger studies has been associated with long cross-clamp times.
References:
Perez de Arenaza D, et al. Randomized Comparison of Stentless Versus Stented Valves for Aortic Stenosis Effects on Left Ventricular Mass. Circulation. 2005;112:2696-2702.
Keywords: Heart Valve Prosthesis, Cardiopulmonary Bypass, Stents, Echocardiography
< Back to Listings
